Schlumbohm EndoPilot Contra-Angle User manual

609 2210 v04 12.05.2020
EndoPilot Contra-Angle
User manual
Processing instruction
Schlumbohm
EN

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2 © Schlumbohm GmbH & Co. KG
Manufacturer information:
Schlumbohm GmbH & Co. KG Phone: [phone] - 8929 - 0
Klein Floyen 8-10 Telefax: +49 (0) 4324 - 8929 - 29
D-24616 Brokstedt [e-mail]
Germany www.schlumbohm.de
WEEE reg. no.: DE 88116129
The manufacturer reserves the right to change the information and data contained in this
user manual without prior notice. On request, the user manual can be provided in different
languages.
This user manual has been prepared with the greatest possible care. However, as errors can
never be fully excluded, we would appreciate any information at any time so we can improve
the documentation for you. Please contact us directly in such an event. Also, should you
have any further questions, please do not hesitate to contact us.
(The data contained in this manual are referred to in the document: 50669 -AEN Rev. 004/24.10.2018)

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Table of contents Page
Introduction ...................................................................................................... 3
Symbols used................................................................................................... 4
First usage – Safety notes................................................................................ 5
Product description........................................................................................... 6
Operation ......................................................................................................... 6
Assembly and removal..................................................................................... 6
Changing of the root canal instruments............................................................ 7
Test run ............................................................................................................ 7
Hygiene and maintenance ................................................................................... 8
Cleaning agents and disinfectants ................................................................... 8
Limitations on processing................................................................................. 8
Initial treatment at the point of use ................................................................... 9
Manual cleaning............................................................................................. 10
Manual disinfection ....................................................................................... 10
Automated cleaning and disinfection ........................................................... 11
Drying ............................................................................................................ 11
Inspection, Maintenance and Testing ............................................................. 11
Lubrication...................................................................................................... 12
Testing after Lubrication ............................................................................... 12
Packaging ...................................................................................................... 13
Sterilization .................................................................................................... 13
Storage........................................................................................................... 14
Accessories.................................................................................................... 14
Technical data ................................................................................................ 14
Temperature information ................................................................................ 15
Ambient conditions......................................................................................... 15
Disposal ......................................................................................................... 15
Disposal of the contra-angle ............................................................................... 15
Disposal of the packaging material ...................................................................... 15
Liability ........................................................................................................... 16
Service ........................................................................................................... 16
Introduction
Customer satisfaction is our top priority. The present device was developed,
manufactured and tested in line with all applicable legal and normative provisions.
For your safety and for the safety of your patients
Prior to first use, please read through the present instructions. The user manual is
intended to give you information and explanations on the use of the device to ensure
undisturbed, economic and safe treatments.
It
explains how to use your medical device and guarantee a smooth and efficient operation.
Observe the safety notes.
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4 © Schlumbohm GmbH & Co. KG
Intended use
Dental contra-angle for the mechanical preparation of root canals on the patient using
root canal instruments
or root canal instruments with alternating movement.
Improper use may lead to damage of the contra-angle, resulting in and increased risk
and hazard to the patient and third persons.
Qualification of the user
We have based our development and design of the medical device on the dentists target
group.
The medical device must be used in accordance with these Instructions for use.
The medical device has no components that can be repaired by the user.
Skilled application
This medical device is intended solely for use by professionals in dental medicine, in
compliance with the applicable occupational health and safety regulations, safety
precautions, and the present instructions for use. It may only be reprocessed and
maintained by persons having undergone training on the prevention of infections, self-
protection and protection of patients. Improper use, e.g. inadequate hygiene and
improper maintenance, non-observance of the present instructions for use, or the use
of non-authorised accessories and spare parts, shall exempt us from any warranty or
other claims.
Symbols used
Description of the symbols used.
Symbol Description
The product complies with the requirements of
EU Regulations / No. of notified body
Caution
Indicates the need for the user to consult the instructions for use for important cautionary information
such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical
device itself. ISO 15223-1:2016 / Ref. 5.5.4 For example: Warning, risk of injuri
Attention! (to prevent damages occurring)
Thermo washer, disinfectable
Steam sterilization up to he stated temperature
General explanations

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Catalogue Number
Indicates catalogue number, part number of device
ISO 15223-1:2016 / Ref. 5.1.6
Serial Number
Serial number so the device can be identified
ISO 15223-1:2016 / Ref. 5.1.7
Waste Collection
Separate collection for waste of electrical and electronic equipment.
EN 50419 - Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC
Do not dispose of with domestic waste
Data Matrix Code for product information
including UDI (Unique Device Identification)
Date of Manufacture
Indicates the medical device manufacturer / Indicates Date of Manufacturer
ISO 15223-1:2016 / Ref. 5.5.1 /5.1.3
Medical Device
This item is a medical-device
ISO 15223-1 draft
Caution!
According to Federal law, this medical device may only be sold by or on the order of a dentist,
physician or any other medical practitioner licensed by the law of the State in which he or she
practices and who intends to use or order the use of this medical device.
First usage – Safety notes
•Before using the medical device for the first time, store it at room temperature for
24 hours.
•The operation of the medical device is permitted only on supply units which
correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN
60601-1-2).
•Always ensure the correct operating conditions.
•Check the medical device for damage and loose parts each time before using
(e.g. push-button).
•Do not operate the medical device if it is damaged.
•Only attach the medical device onto the motor when the motor is at a complete
standstill.
•Do not activate the push-button of the medical device during operation. This
leads to detachment of the root canal instrument and/or makes the medical
device hot.
•Perform a test run each time before using.
•Do not touch the soft tissue with the contra-angle head (risk of burning due to
the push-button heating up)!
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Hygiene and maintenance prior to initial use
The medical device is sealed in PE film and not sterilized when delivered.
The PE film and the packaging are non-sterilizable.
Prior to first use, the contra-angle has to be c leaned, disinfected, lubricate and sterilized.
See chapter 6. “Hygiene and maintenance”
Product description
Press button Handle sleeve
Operation
Assembly and removal
Do not insert assemble or remove the
contra-angle while in operation!
1. Connect the contra-angle to the
motor until it snaps into place
2. Check if the contra-angle is tightly
fastened to the motor
3. Remove the contra-angle by
pulling it in axial direction
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Changing of the root canal instruments
Root canal instruments
• Please make sure to solely use
root canal instruments in perfect
technical condition.
• Please observe the
manufacturer’s instructions.
• Please insert the root canal
instrument only when the contra-
angle is at still stand.
• Don’t ever touch the root canal
instrument when it is still rotating
or running out.
• Don’t ever press the press button
on the contra-angle while the
contra-angle is still rotating or
running out. This may result in
the root canal instrument
loosening, or the press button
getting hot.
•
We recommend to use always a rubber dam.
1. Insert the instrument until the stop position is reached (a)
and turn it until it locks in place b).
2. Check if the instrument is safely locked in place by pulling it in axial direction (b).
3. To remove the instrument, press the press button.
Verify full engagement.
Test run
Do not hold the medical device at eye level
1. Insert the root canal instrument.
2. Start the contra-angle on the motor.
3. In case of operating malfunctions (for example vibrations, unusual noise,
overheating), please make sure to put the contra-angle out of operation
immediately and contact the
Schlumbohm®customer service (see chapter 11).
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Hygiene and maintenance
General notes
•
Observe the specific guidelines, standards, directives and laws regarding
cleaning, disinfection and sterilization in your country.
•
The contra-angle may be reprocessed either manually or mechanically.
• Wear protective clothing, safety glasses, face mask and gloves.
• Remove the root canal instrument from the contra-angle.
•
Disconnect the contra-angle from the motor.
• Please make sure to disinfect the contra-angle immediately after every
treatment to flush out any liquids that might have penetrated the contra-angle
(for example blood, saliva, etc.), and to prevent clogging of the internal parts.
• After manual or mechanical cleaning and disinfection and maintenance with oil,
the contra-angle needs to be sterilized.
•Use only oil-free, filtered compressed air with a maximum operating pressure of 3
bar for manual drying.
Cleaning agents and disinfectants
•Read the notes, follow the instructions and heed the warnings provided by the
manufacturers of cleaning
•Agents and/or disinfectants.
•Use only detergents which are intended for cleaning and/or disinfecting medical
devices made of metal
•And plastic.
•It is imperative to comply with the concentrations and exposure times specified by the
manufacturer of the disinfectant.
•Use disinfectants which have been tested and found effective by the Verbund für
Angewandte Hygiene e.V (VAH = Association for Applied Hygiene), the
Österreichischen Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin
(ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the
Food and Drug Administration (FDA) and the U.S. Environmental Protection
Agency (EPA).
The user is responsible for validating its process if the specified cleaning agents
and disinfectants are not available.
Limitations on processing
The product lifetime and the medical device’s ability to operate correctly are mainly
determined by mechanical stress during use and chemical influences due to
processing.

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Send worn or damaged contra-angles or contra-angles with material changes to the
Schlumbohm®customer service.
Processing cycles:
We recommend a regular service for the contra-angle after 1000 processing cycles or
one year.
Initial treatment at the point of use
•Clean the medical device immediately after every treatment, to flush out any liquid
(e.g., blood, saliva etc.) and to prevent settling on the internal parts.
•Operate the medical device for at least 10 seconds at idle speed
•Ensure that all outlets are rinsed out
•
Wipe the entire surface of the instrument with disinfectant.
•Remove the root canal instrument.
• Remove the contra-angle from the motor
Note that the disinfectant used during pre-
treatment is only for personal protection and
cannot replace the disinfectant step after
cleaning.
EN

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10 © Schlumbohm GmbH & Co. KG
Manual cleaning
Do not place the contra-angle in liquid disinfectant or in an ultrasonic bath
1. Rinse contra-angle under running tap
water.
(<35°C / 95°F). Rinse and brush off
all internal and external surfaces.
Move moving parts back and forth several
times.
2.
Remove any liquid residues using oil-free,
filtered compressed air.
Manual disinfection
We recommend wiping down the contra-angle with disinfectant
Evidence of the medical device’s basic suitability for
effective manual disinfection was provided by an
independent test laboratory using the »mikrozid®
AF wipes« disinfectant (Schülke & Mayr GmbH,
Norderstedt, Germany).
If this product is not available, »CaviWipes®« dis-
infectant (Metrex LLC, Orange, CA 92867 USA)
is an alternative.

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Automated cleaning and disinfection
We recommend automated cleaning and disinfection using a washer-disinfector
(WD).
Read the notes, follow the instructions and heed the warnings provided by the
manufacturers of washer-disinfectors, cleaning agents and/or disinfectants.
Evidence of the medical device’s basic suitability for effective automated disinfection
was provided by an independent test laboratory using the »Miele PG 8582 CD«
washer-disinfector (Miele & Cie. KG, Gütersloh) and the »Dr. Weigert neodisher®
MediClean forte« cleaning agent (Dr. Weigert GmbH & Co. KG, Hamburg).
Cleaning at 55 °C (131 °F) – 5 minutes
Disinfection at 93 °C (200 °F) – 5 minutes
Drying
Ensure that the medical device is completely dry internally and externally after
cleaning and disinfection.
Remove any liquid residues using oil-free, filtered compressed air.
Inspection, Maintenance and Testing
•Check the contra-angle after cleaning and disinfection for damage, visible residual
soiling and surface changes.
•Reprocess the contra-angle if it is still soiled.
•Sterilize the contra-angle after cleaning, disinfection and lubrication.
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Lubrication
Lubricate the dry medical device immediately after cleaning and/or disinfection.
Recommended lubrication cycles:
•Essential after every internal cleaning
•Before each sterilization or
•After 30 minutes of use or at least once daily
•Chucking system once a week
1.
Lubricate the contra-angle with oil, for
example with W&H Service Oil F1, MD-
400. Please follow the instructions of use
printed on
the aerosol can and on the
packaging .
Or
2.
Lubricate the contra-angle in an automatic
instrument maintenance device, for
example in the W&H Assistina 301plus (see
instructions for use coming with the device).
After maintenance, please place the contra-angle in an upright position on a clean
disposable cloth. This way, excessive oil may drip off so that it cannot get into the
motor.
Testing after Lubrication
1.
Hold the contra-angle with the head pointing
downwards.
2.
Let the contra-angle run briefly so that excess
oil can escape. To do so, please start the
calibration function of the EndoPilot. In case of
dirt leaking from the contra-angle, the entire
hygiene and maintenance procedure must be
repeated.
3.
Wipe the contra-angle with disinfectant wipes.

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Packaging
Pack the contra-angle in sterilization packages that meet the following
requirements:
• The sterilization package must meet the applicable standards in respect of quality
and use and must be suitable for the sterilization method.
(For the US: The package must follow the FDA requirements)
•The sterilization package must be large enough for the sterilization goods.
•The filled sterilization package must not be under tension.
Sterilization
We recommend sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79.
Read the notes, follow the instructions and heed the warnings provided by the
manufacturers of steam sterilizers.
The program selected must be suitable for the medical device.
Recommended sterilization procedure:
•Fractionated pre-vacuum process (type B)
•Gravity displacement process (type N)
•Sterilization time at least 30 minutes at 121°C (250°F) or at least 3 minutes at
134°C (273°F)
•Maximum sterilization temperature 135°C (275°F)
Evidence of the medical device’s basic suitability for effective sterilization was
provided by an independent test laboratory using the LISA 517 B17L steam sterilizer
(Firma W&H Sterilization S.r.l., Brusaporto (BG)) and the CertoClav MultiControl
MC2-S09S273 gravitation sterilizer (CertoClav GmbH, Traun).
•Fractionated pre-vacuum process (type B):
temperature 134°C (273°F) – 3 minutes*
•Gravity displacement process (type N):
temperature121°C (250°F) – 30 minutes**
* According to EN 13060:2014 A1:2018, EN 285:2015, ISO 17665:2017
** according to ANSI/AAMI ST55:2016, ANSI/AAMI ST79:2017
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Storage
Store sterile goods dust-free and dry
The shelf life of the sterile goods depends on the storage conditions and type of packaging
Accessories
The equipment used must be suitable for dental instruments and contra-angles.
For example:
REF 00030140 W&H Assistina 301plus
REF 10940021 W&H Service Oil F1, MD-400 (6 pcs)
REF 02038200 W&H Spray adaptor
Technical data
* By choosing the right conditions of operation, the user has to make sure to exclude any hazard to
the user, patient or third persons. Please observe the instructions of the root canal instrument
manufacturer (in terms of speed, torque and type of movement))
Gear ratio 1:1
Motor coupling in compliance with standard ISO 3964: 2016 + Amm.2018
Recommended root canal instruments*
Shank diameter of the instruments (Type 1)
acc. to ISO14457:2017
NiTi files for the mechanical prepara-
tion of root canals
Ø 2,35* mm
Minimum insertion depth
until the instrument is firmly locked in
place
A maximum motor rotational speed for NiTi files of
2000 rpm:
equals a rotational speed of operation of 2000 rpm
2000 rpm

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Temperature information
Temperature of the medical device on the operator side:
maximum 55°C (131°F)
Temperature of the medical device on the patient side:
maximum 50°C (122°F)
Temperature of the working part (rotary instrument): maximum
41°C (105,8 °F)
Ambient conditions
Temperature during storage and transport: -40°C to +70°C (-40°F to
158°F)
Humidity during storage and transport: 8% to 80% (relative), non-
condensing
Temperature during operation: +10°C to +35°C (+50°F to +95°F)
Humidity during operation: 5% to 80% (relative), non-condensing
Disposal
Ensure that the parts are not contaminated on disposal.
Disposal of the contra-angle
Follow your local and national laws, directives, standards and guidelines for
disposal
.
Disposal of the packaging material
The packaging materials were duly selected to allow an environmentally friendly
disposal, therefore, all components can be recycled. Please dispose of all no longer
required packaging materials in the collection and recycling system. In so doing, you
can contribute to recycle raw materials and to reduce waste.
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Liability
Schlumbohm®warrants this product against defects in materials and workmanship for the
period of one year from the date of the original invoice. The product warrant provided by
Schlumbohm® includes the repair or the replacement of the entire device or individual parts.
The decision whether to replace or repair is entirely up to the manufacturer.
In the event of an alleged defect during warranty, the customer has to inform the customer
service immediately. The customer service will give further instructions. Normally you will be
asked to return the contra-angle. The costs of returning the product are at the sender’s
expense.
Application errors exclude a warranty. Schlumbohm®does not warrant for wear and
contamination of the handpieces and contra-angles.
Schlumbohm®declines all responsibility for any damage caused as a result of the clinical
application of its products. Irrespective of whether or not such use is associated with other
medical devices (e.g. pacemakers).
Service
In case of operating malfunctions , you are requested to immediately contact your dealer
or the
Schlumbohm®customer service . Repair and maintenance may only be carried out
by the
Schlumbohm®customer service
Ensure that the medical device has been completely processed before returning it.
Manufacturer:
Schlumbohm GmbH & Co. KG Phone: [phone] - 8929 - 0
Klein Floyen 8-10 Fax: [phone] - 8929 - 29
D-24616 Brokstedt [e-mail]
Germany www.schlumbohm.com