W&H SURGICAL WS-56 L User manual

Instructions for Use
Surgical
Contra-angle handpieces
WS-56 L, WS-75 L, WS-91 L, WS-92 L
with mini LED+

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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........................................................................................................................................................... 13
4. Operation............................................................................................................................................................................ 15
Assembly/Removal ............................................................................................................................................................................15
Rotary instruments............................................................................................................................................................................19
To change the rotary instrument...................................................................................................................................................... 20
Test run .............................................................................................................................................................................................. 24
5. Hygiene and maintenance................................................................................................................................................ 25
General notes..................................................................................................................................................................................... 25
Limitations on processing................................................................................................................................................................ 27
Contents

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Initial treatment at the point of use................................................................................................................................................. 28
Manual cleaning ................................................................................................................................................................................ 29
Manual disinfection .......................................................................................................................................................................... 35
Automated cleaning and disinfection.............................................................................................................................................. 36
Drying ................................................................................................................................................................................................ 38
Inspection, Maintenance and Testing.............................................................................................................................................. 39
Packaging .......................................................................................................................................................................................... 44
Sterilization........................................................................................................................................................................................ 45
Storage............................................................................................................................................................................................... 48
6. Servicing ............................................................................................................................................................................ 49
7. W&H Accessories and spare parts...................................................................................................................................50
8. Technical data.................................................................................................................................................................... 52
9. Disposal ............................................................................................................................................................................. 55
Explanation of warranty terms............................................................................................................................................. 56
Authorized W&H service partners........................................................................................................................................ 57

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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!
(if persons could
be injured)
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.
Symbols in the Instructions for Use

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Catalogue number
Serial number
Thermo washer
disinfectable
Sterilizable up to the
stated temperature
Date of manufacture
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
Symbols on the medical device / packaging
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
Surgical treatment of organic hard tissue.
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
We have based our development and design of the medical device on the physician 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 57).

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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.
> 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 coolant function.
> Always ensure that sufficient and adequate coolant is delivered and ensure adequate suction.
> In case of coolant supply failure, the medical device must be stopped immediately.
> 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
rotary instrument and/or makes the medical device hot.
> Perform a test run each time before using.
> Avoid overheating at the treatment site.
2. Safety notes

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> Do not touch the soft tissue with the contra-angle head (risk of burning due to the push-button heating up)!
> Avoid contact between LED and soft tissue (risk of burning due to the LED heating up).
> Do not use the medical device as a light probe.
> Do not look directly into the LED.
The medical device is not approved for operation in potentially explosive atmospheres.

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Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemaker 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.
> 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.

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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, the nozzle cleaner, the Y-manifold, the spray clips and the coolant tube for
internal bur cooling system.

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WS-56 L, WS-75 L, WS-91 L, WS-92 L
LED
Push-button
Contra-angle head*
Middle gear
Knee
Sheath*
* Symbols on parts and 
Sheath open
Direction of rotation
Sheath locked
3. Product description

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WS-75 L
Hexagon chucking system
Coolant tube for internal bur cooling
system
Y-manifold
WS-91 L, WS-92 L
External coolant tube
Spray nozzles
WS-56 L, WS-75 L
 
Spray clips for the left and right
WS-56 L, WS-75 L, WS-91 L, WS-92 L
Nozzle cleaner
Kirschner/Meyer internal
bur cooling system
without internal
bur cooling system
Product description

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Do not assemble or remove the medical device during operation!
The medical device is matched to W&H electric motor EM-19 LC / EM-19 and to W&H Implantmed SI-10xx.
You can only make full use of all the medical device's advantages in this combination (e.g., constant
illumination at every speed).
The medical device may only be used with W&H electric motor EM-19 LC / EM-19.
The user accepts sole responsibility if the medical device is used on other electric motors.
The manufacturer accepts no liability.
4. Operation Assembly/Removal

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WS-56 L
Spray clip
WS-75 L
Spray clip
Coolant tube for internal bur cooling system
Attach the spray clip.
Insert the coolant tube for internal bur cooling
system.
or
Remove the coolant tube for internal bur cooling
system.
Remove the spray clip.

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Medical device
Push the medical device onto the motor and turn
until it engages audibly.
Verify secure hold.
or
Remove the medical device.

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WS-75 L
Y-manifold
Only when using the coolant tube for
internal bur cooling system.
Insert the coolant hose of the Y-manifold onto the
coolant tube of the spray clip and onto the coolant
tube for internal bur cooling system.
Insert the Y-manifold into the irrigation tubing.
or
Remove the Y-manifold.

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Rotary instruments
> Use only rotary instruments which are in perfect condition and pay attention to the direction of rotation of
the rotary instrument. Follow the operating instructions of the manufacturer.
> Insert the rotary instrument only when the medical device is stationary.
> Never touch the rotary instrument while it is still rotating.
> Do not activate the push-button of the medical device during operation. This leads to detachment of the
rotary instrument and/or makes the medical device hot.
When having a torque higher than 30 Ncm on the rotary instrument you have to use hardened shafts
(>50 HRC, >520 HV) (risk of deformation).

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To change the rotary instrument
WS-56 L
> Instrument shaft diameter 2.35 mm
Insert the rotary instrument until the limit stop.
Turn the rotary instrument until it engages.
Verify secure hold.
or
Activate the push-button and remove the rotary
instrument.