W&H EM-19 User manual

Instructions for use
Electric motor
EM-19 / EM-19 LC

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Symbols....................................................................................................................................................................................4
in the Instructions for use ...................................................................................................................................................................4
on the medical device / packaging......................................................................................................................................................5
1. Introduction .........................................................................................................................................................................6
2. Safety notes ........................................................................................................................................................................9
3. Product description........................................................................................................................................................... 12
4. Operation............................................................................................................................................................................ 13
Assembly/Removal ............................................................................................................................................................................14
Test run ...............................................................................................................................................................................................15
5. Hygiene and maintenance................................................................................................................................................ 16
General notes......................................................................................................................................................................................16
Limitations on processing ................................................................................................................................................................ 18
Initial treatment at the point of use..................................................................................................................................................19
Manual cleaning ................................................................................................................................................................................ 20
Contents

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Manual disinfection ...........................................................................................................................................................................21
Automated cleaning and disinfection.............................................................................................................................................. 22
Drying .................................................................................................................................................................................................23
Inspection, Maintenance and Testing.............................................................................................................................................. 24
Packaging .......................................................................................................................................................................................... 25
Sterilization........................................................................................................................................................................................ 26
Storage............................................................................................................................................................................................... 28
6. Servicing ............................................................................................................................................................................ 29
7. W&H Accessories and spare parts................................................................................................................................... 31
8. Technical data ................................................................................................................................................................... 32
9. Data on electromagnetic compatibility according to IEC/EN 60601-1-2...................................................................... 34
10. Disposal ........................................................................................................................................................................... 38
Explanation of warranty terms............................................................................................................................................. 39
Authorized W&H service partners........................................................................................................................................ 40

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Do not dispose of with
domestic waste
General explanations,
without risk to
persons or objects
ATTENTION!
(to prevent
damage occurring)
WARNING!
(risk of injury)
Symbols in the Instructions for use
Caution!
Federal law restricts this device to sale by or on the order of a dentist, physician, veterinarian or with the
descriptive designation of any other practitioner licensed by the law of the State in which the practitioner
practices to use or order the use of the device.

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Symbols on the medical device / packaging
Catalogue number
Serial number
CE marking
with identification number
of the Notified Body
UL Component Recognition
Mark indicates compliance
with Canadian and U.S.
requirements
DataMatrix Code
for product information
including UDI (Unique
Device Identification)
Data structure in
accordance with Health
Industry Bar Code
Type B applied part (not
suitable for intracardiac
application)
Date of manufacture
Temperature limitation
-40°C (-40°F) Min.
+70°C (+158°F)Max.
Humidity limitation
8 %
80 %
Sterilizable up to the stated
temperature
Thermo washer
disinfectable
Manufacturer
Medical device
Consult Instructions for Use
XXXX

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Customer satisfaction has absolute priority in the W&H quality policy. This medical device has been developed,
manufactured and subjected to final inspection according to legal regulations, quality and industry standards.
For your safety and the safety of your patients
Prior to initial use please read the Instructions for use. These explain how to use your medical device and guarantee
a smooth and efficient operation.
Observe the safety notes.
Intended use
Electrical drive for transmission instruments with ISO 3964 (DIN 13940) compatible coupling system, for use in
dental surgery, implantology and maxillofacial surgery (CMF).
Misuse may damage the medical device and hence cause risks and hazards for patient, user and
third parties.
1. Introduction

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Qualifications of the user
Only suitably qualified medical, technical and specialist trained staff may use the medical device.
We have based our development and design of the medical device on the physician target group.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device
when it is used in compliance with the following directions:
> 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.
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 40).

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Skilled application
The medical device is intended only for skilled application according to the intended use as well as in compliance
with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with
these Instructions for use.
The medical device should be prepared for use and maintained by staff who have been trained in procedures for
infection control, personal safety and patient safety.
Improper use, (e.g., through poor hygiene and maintenance), non-compliance with our instructions or the use of
accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any
other claims.
Any serious incident that has occurred in relation to the medical device should be reported to the
manufacturer and the competent authority!

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> Before using the medical device for the first time, store it at room temperature for 24 hours.
> Check the medical device for damage and loose parts each time before using.
> Do not operate the medical device if it is damaged.
> Always ensure the correct operating conditions.
> Check the parameter settings every time you restart.
> Perform a test run each time before using.
> Ensure that it is possible to complete the operation safely should the units or instruments fail.
> Do not twist or kink the motor cable! Do not coil it too tightly!
> Moisture in the medical device may cause a malfunction! (Risk of short circuit)
> The medical device must not be disassembled.
> The medical product is lubricated for life and therefore should not be lubricated.
The medical device is not approved for operation in potentially explosive atmospheres.
2. Safety notes

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Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter
defibrillator (ICD) can be affected by electric, magnetic and electromagnetic fields.
> Find out if patient and user have implanted systems before using the medical device and consider the
application.
> Weigh the risks and benefits.
> Keep the medical device away from implanted systems.
> Do not place the motor on the patient’s body.
> Make appropriate emergency provisions and take immediate action on any signs of ill-health.
> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac
pacemaker or ICD.
Rotational energy
Fast deceleration of the bur can, at times, cause the selected torque to be temporarily exceeded,
compared to the value set, as a result of the rotational energy stored in the drive system.

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Transmission instruments
> Follow the directions and safety notes in the Instructions for Use of the transmission instruments.
> Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and
manufacturerapproved transmission instruments.
> Follow the directions of the manufacturer of transmission instruments with reference to transmission
ratio, maximum speed and maximum torque.
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.
> Clean and disinfect the medical device.
> Sterilize the medical device.






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Motor sheath
Electrical contacts*
O-Ring
Motor cable
*only EM-19 LC
3. Product description

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4. Operation


Do not assemble or remove the medical
device during operation!
Connect motor cable.
Pay attetion to the positioning.
Verify full engagement.

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Assembly/Removal
Operation
Do not assemble or remove the medical
device during operation!
Push the transmission instrument onto the
medical device and turn it until it engages audibly.
Verify full engagement.
Remove the transmission instrument from the
medical device by pulling in an axial direction.

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Test run
Do not hold the medical device at eye level.
> Start the medical device using the attached transmission instrument.
In the event of operating malfunctions (e.g., vibrations, unusual noise or overheating)stop the medical device
immediately and contact an authorized W&H service partner.

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> Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection
and sterilization.
> Wear protective clothing, safety glasses, face mask and gloves.
> Remove the transmission instrument from the medical device.
> Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying.
5. Hygiene and maintenance General notes

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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.

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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.
> Send worn or damaged medical devices and/or medical devices with material changes to an authorized
W&H service partner.
Processing cycles
> We recommend a regular service for the W&H medical device after 500 processing cycles or one year.
Hygiene and maintenance Limitations on processing

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> Clean the medical device immediately after every treatment.
> Wipe the entire surface of the meeical device with disinfectant.
Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the
disinfectant step after cleaning.
Hygiene and maintenance Initial treatment at the point of use

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Hygiene and maintenance Manual cleaning
Do not place the medical device in liquid disinfectant or in an ultrasonic bath.
> Clean the medical device under running tap water (<35°C / 95°F).
> Rinse and brush off all internal and external surfaces.
> Remove liquid residues using compressed air.