W&H proxeo ULTRA PB-5 L User manual

Instructions for use
Handpiece
PB-5 L, PB-5 L S, PB-5 L Q

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Contents
Symbols....................................................................................................................................................................................4
in the Instructions for use.................................................................................................................................................................. 4
on the medical device ........................................................................................................................................................................ 5
packaging ............................................................................................................................................................................................ 6
1. Introduction .........................................................................................................................................................................7
2. Safety notes ......................................................................................................................................................................10
3. Product description........................................................................................................................................................... 15
4. Operation............................................................................................................................................................................16
Assembly/Removal........................................................................................................................................................................... 16
Changing the tip.................................................................................................................................................................................17
Test run..............................................................................................................................................................................................20
5. Hygiene and maintenance ................................................................................................................................................21
General notes .....................................................................................................................................................................................21
Limitations on processing................................................................................................................................................................ 23

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Initial treatment at the point of use................................................................................................................................................. 24
Manual cleaning................................................................................................................................................................................ 25
Manual disinfection.......................................................................................................................................................................... 29
Automated cleaning and disinfection..............................................................................................................................................30
Drying ................................................................................................................................................................................................ 31
Inspection, Maintenance and Testing.............................................................................................................................................. 32
Packaging ..........................................................................................................................................................................................34
Sterilization ....................................................................................................................................................................................... 35
Storage...............................................................................................................................................................................................38
6. Exchanging the supply hose O-rings...............................................................................................................................39
7. Servicing.............................................................................................................................................................................40
8. W&H Accessories and spare parts................................................................................................................................... 41
9. Technical data....................................................................................................................................................................42
10. Disposal............................................................................................................................................................................44
Explanation of warranty terms.............................................................................................................................................45
Authorized W&H service partners ....................................................................................................................................... 47

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in the Instructions for use
WARNING!
(risk of injury)
ATTENTION!
(to prevent
damage occurring)
General explanations,
without risk to
persons or objects
Symbols
Do not dispose of
with domestic waste
Type B applied part
(not suitable for
intracardiac application)

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Symbols on the medical device
Data structure in
accordance with
Health Industry Bar Code
DataMatrix Code
for product information
including UDI (Unique
Device Identification)
Date of manufacture
Serial number
Catalogue number
CE marking
with identification number
of the Notified Body
XXXX
Thread system:
Q-Link
W&H
Satelec
Sterilizable up to the
stated temperature
Thermo washer
disinfectable
Suitable for people with
pacemakers or implanted
defibrillators

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Symbols
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
XXXX
packaging
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 intends to use or order the use of this medical device.

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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
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for
the removal of supragingival calculus and subgingival concretions and for endodontics application and preparation of
tooth enamel.
Misuse may damage the medical device 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, dental hygienists, dental
employees (prophylaxis) and dental assistants 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 47).
> Unauthorized opening of the medical device invalidates all claims under warranty and any other claims.

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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, unauthorized assembly, modification or repair to the medical device, 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.
> Always ensure the correct operating conditions and cooling function.
> Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction
(except for tips where no coolant is used).
> In case of coolant supply failure, the medical device must be stopped immediately (maximum operating
time without coolant is 30 seconds). The exception are applications where no coolant is used
(e.g. endodontics). Maximum operating time without coolant is 2 minutes.
> Check the medical device for damage and loose parts each time before using (e.g., tip, handpiece cap).
> Do not operate the medical device if it is damaged.
> Perform a test run each time before using.
> Do not look directly into the optic outlet.
> Run the rinse function for the dental unit once per day.
> Replace damaged or leaking O-rings immediately.
> Do not twist, kink or squeeze the supply hose (risk of damage).

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Tips
> Only use tips that have been approved by W&H and the associated tip changers or spanners.
> An overview of the correct power settings is included with every tip.
> With periodontal tips, the medical device is suitable for the removal of concretions in the subgingival
region, but not for applications which demand sterile conditions. Choose the lower performance range
when carrying out periodontal treatments on hypersensitive patients in order to guarantee optimum
pain-free treatment.
> Ensure that the original shape of the tips is not affected (e.g. by being dropped).
> The tips must not be bent back into shape or resharpened.
> Locate and secure the tip only with the medical device switched off.
> Never touch the tips when vibrating.
> Insert the tip changer onto the inserted tip of the stationary medical device after every treatment
(protection against injury and infection, tip protection). Tips that are changed using a spanner must be
removed from the medical device immediately after treatment.
> Do not touch into the tip changer (with tip inserted).
> Check for the effect of wear on the tips using the accompanying tip card.
> Change tips if there are visible signs of wear.

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Approved coolants and rinsing liquids
> Physiological saline solution (NaCl, 0.9%)
> Hydrogen peroxide (HO, 1–3%)
> Liquids with the active substance chlorhexidine (CHX, 0.2%)
> Tap water

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The medical device is tailored to the W&H supply hose and the W&H control electronics and must therefore
only be used with W&H products. Using other components could lead to deviating parameters or even the
destruction of the system.
Risks due to electromagnetic fields
This medical device complies with the reference values defined in EN 50527-2-1/2016 for active implantable
medical devices (AIMD) and cardiac pacemakers.
The medical device is not approved for operation in potentially explosive atmospheres.

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Hygiene and maintenance prior to initial use
> The medical device is not sterilized when delivered.
> The packaging is non-sterilizable.
> Clean and disinfect the medical device, the tips and the tip changer.
> Sterilize the medical device, the tips and the tip changer.

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3. Product description
Thread
Connection for supply hose
Handpiece cap
Optical fibre
Optic outlet
Nozzle cleaner






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4. Operation Assembly/Removal
Push the medical device onto the supply hose.
Note the positioning.
Remove the medical device.



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Operation Changing the tip
Insert tip with tip changer
Ensure the matching thread system
(at the handpiece, tip changer, tip)!
Position the tip on the thread of the
medical device.
Turn the tip changer until it audibly engages.
Withdraw the tip changer.
Verify full engagement.
Press the tip with about 1 N (= 100 g)
pressure onto a firm object to test the
loading capacity of the tip.




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Remove tip with tip changer
Place the tip changer onto the tip.
Unscrew the tip with the tip changer.
Leave the tip in the tip changer until the
hygienic maintenance process!



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Insert/remove tip with spanner
Position the tip on the thread of the
medical device.
Screw the tip down.
Verify full engagement.
Unscrew the tip.




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Test run
Do not hold the medical device at eye level!
> Attach the medical device to the supply hose.
> Insert the tip.
> Put the medical device into operation.
In the event of operating malfunctions (e.g. vibrations, unusual noise, overheating, coolant supply failure or
leakage) stop the medical device immediately and contact an authorized W&H service partner.