W&H endea EB-62 User manual

Contra-angle handpieces
Endea Endo Cursor – EB-62
Endea – EB-75 / EB-79
Contra-angle handpieces
Endo NiTi – WD-73 M / WD-74 M
Instructions for Use

Contents
Symbols....................................................................................................................................................................................4
in the Instructions for use.................................................................................................................................................................. 4
on the medical device / packaging..................................................................................................................................................... 5
1. Introduction .........................................................................................................................................................................6
2.Safety notes .........................................................................................................................................................................9
3. Product description........................................................................................................................................................... 11
Endea Endo Cursor............................................................................................................................................................................ 11
Endea NiTi, Endea...............................................................................................................................................................................12
4. Operation............................................................................................................................................................................ 13
Assembly / Removal ......................................................................................................................................................................... 13
Changing the root canal instrument................................................................................................................................................ 15
Test run.............................................................................................................................................................................................. 16
5. Hygiene and maintenance ............................................................................................................................................... 17
General notes .....................................................................................................................................................................................17
Limitations on processing................................................................................................................................................................ 19
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Initial treatment at the point of use.................................................................................................................................................20
Manual cleaning.................................................................................................................................................................................21
Automated cleaning and lubrication................................................................................................................................................22
Manual cleaning................................................................................................................................................................................ 23
Automated cleaning and disinfection.............................................................................................................................................. 24
Drying ................................................................................................................................................................................................ 25
Inspection, Maintenance and Testing.............................................................................................................................................. 26
Packaging .......................................................................................................................................................................................... 29
Sterilization .......................................................................................................................................................................................30
Storage............................................................................................................................................................................................... 32
6. Servicing............................................................................................................................................................................33
7. W&H Accessories and spare parts...................................................................................................................................34
8. Technical data....................................................................................................................................................................35
9. Disposal .............................................................................................................................................................................39
Explanation of warranty terms.............................................................................................................................................40
Authorized W&H service partner ......................................................................................................................................... 41
3

in the Instructions for use
WARNING!
(risk of injury)
ATTENTION!
(to prevent
damage occurring)
General explanations,
without risk to
persons or objects
Do not dispose of with
domestic waste
Symbols
4

Symbols on the medical device / packaging
Catalogue number
CE marking
with identification number
of the Notified Body
DataMatrix Code
for product information
including UDI (Unique
Device Identification)
Data structure in
accordance with
Health Industry Bar Code
UL Component Recognition Mark
indicates compliance with Canadian and U.S. requirements
Serial number
Date of manufacture
XXXX
Thermo washer
disinfectable
Sterilizable up to the
stated temperature
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. 5

1. Introduction
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
Dental contra-angle handpiece for mechanical root canal preparation on patients, using rotary root canal
instruments or root canal hand instruments with alternating 60° movement.
Misuse may damage the handpiece and hence cause risks and hazards for patient, user and third parties.
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Qualifications of the user
We have based our development and design of the medical device on the dentists target group.
Production according to EU Directive
The medical device meets the requirements of Directive 93/42/EEC.
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 41).
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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.
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2.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 and cooling function.
> 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.
> Clean, disinfect and lubricate the medical device.
> Sterilize the medical device.
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