W&H Proxeo Ultra PB-510 User manual

Instructions for Use
PB-510, PB-520, PB-530

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 8
2. Electromagnetic compatibility (EMC)................................................................................................................................................... 10
3. Unpacking ................................................................................................................................................................................................ 11
4. Scope of delivery......................................................................................................................................................................................12
5. Safety notes .............................................................................................................................................................................................13
6. Description............................................................................................................................................................................................... 18
Control unit PB-510............................................................................................................................................................................. 18
Control unit PB-520............................................................................................................................................................................. 19
Control unit PB-530 ............................................................................................................................................................................ 20
Foot control C-NF/C-NW.......................................................................................................................................................................21
Status LED foot control C-NW............................................................................................................................................................. 22
7. Start-up..................................................................................................................................................................................................... 23
Control unit general ............................................................................................................................................................................ 23
Control unit PB-530 ............................................................................................................................................................................ 25
Functions control units ...................................................................................................................................................................... 28
8. Operation control unit............................................................................................................................................................................. 29
Rinsing function.................................................................................................................................................................................. 29
Cleaning function................................................................................................................................................................................ 30
Start-up................................................................................................................................................................................................ 31
9. Error messages........................................................................................................................................................................................ 33
10. Hygiene and maintenance ................................................................................................................................................................... 35

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Contents
11. Maintenance .......................................................................................................................................................................................... 36
Replacing the O-ring of the coolant tank ........................................................................................................................................... 36
Replacing the coolant filter of the coolant hose ............................................................................................................................... 36
Replacing the pump cartridge............................................................................................................................................................ 37
12. Servicing ................................................................................................................................................................................................ 38
13. W&H accessories and spare parts....................................................................................................................................................... 40
14. Technical data........................................................................................................................................................................................ 42
15. Disposal ................................................................................................................................................................................................. 45
Explanation of warranty terms................................................................................................................................................................... 46
Authorised W&H service partners ............................................................................................................................................................. 47
Manufacturer’s declaration......................................................................................................................................................................... 48

4
Symbols
WARNING!
(risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations,
without risk to persons or objects
in the Instructions for Use

5
Symbols
Consult Instructions for Use
Foot control
Catalogue number
Serial numberDataMatrix Code
for product information
including UDI (Unique
Device Identification)
Do not dispose of with
domestic waste
Date of manufacture
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005,
ANSI/AAMI ES60601-1: A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012,
CAN/CSA-C22.2 No. 60601-1:2008, CSA CAN/CSA-C22.2 NO. 60601-1:2014.
25UX – Control No.
25UX
on the medical device
Non-ionizing electromagnetic
radiation
DC – direct current
Supply voltage
Electric power consumption
Frequency of the
alternating current
V
W
Hz
Coolant volume
Upper limit of temperature
+30°C Max.
(+86°F)
ESI (External System Interface)
CE mark
with identification number
of the Notified Body
XXXX
Follow Instructions for Use

6
Symbols
UL Component Recognition
Mark indicates compliance
with Canadian and
U.S. requirements
Non-ionizing electromagnetic
radiation
DC – direct current
Do not dispose of with
domestic waste
Protection against
dripping water
IPX1
Catalogue number
Serial number
Date of manufacture
DataMatrix Code
for product information
including UDI (Unique
Device Identification)
CE mark
with identification number
of the Notified Body
XXXX
Wireless foot control C-NW
on the foot control
Reset

7
Symbols
This way up
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.
Fragile, handle with care
Keep dry
Temperature limitation
Humidity limitation
»Der Grüne Punkt« (The Green Dot)
trademark of Duales System
Deutschland GmbH
Trademark of RESY OfW GmbH
for identification of recyclable
transport and outer packaging
of paper and cardboard
-20 °C (-4°F) Min.
+60 °C (+140°F)Max.
8 %
80 %
CE mark with identification number
of the Notified Body
XXXX
Data structure in accordance with
Health Industry Bar Code
DataMatrix Code
for product information including UDI
(Unique Device Identification)
on the packaging

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1. Introduction
For your safety and the safety of your patients
These Instructions for Use explain how to use your medical device. However, we must also warn against possible hazardous
situations. Your safety, the safety of your team and, of course, the safety of your patients are of paramount importance to us.
Observe the safety notes.
Intended use
PB-510, PB-520, PB-530:
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 endodontic application and preparation of tooth enamel.
C-NF, C-NW: Foot control for operation of medical electrical equipment.
Misuse may damage the medical device and hence cause risks and hazards for user and third parties.
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.

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Introduction
Production according to EU Directive
The medical device meets the requirements of Directive 93/42/EEC.
The foot control meets the requirements of Directive 93/42/EEC and RED Directive 2014/53/EU.
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.
> Only the components approved by the manufacturer may be replaced (O-ring, coolant filter, pump cartridge).
> Modifications or repairs must only be undertaken by an authorised W&H service partner (see page 47).
> The medical device has no components that can be repaired by the user.
> The electrical installation at the premises must comply with the regulations laid out in IEC 60364-7-710 (»Installation of
electrical equipment in rooms used for medical purposes«) or with the regulations applicable in your country.
> Unauthorized opening of the medical device invalidates all claims under warranty and any other claims.
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. Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into
operation in accordance with the EMC notes included.
W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories
and spare parts. The use of accessories and spare parts not approved by W&H can lead to an increased emission of
electromagnetic interference or to a reduced resistance against electromagnetic interference.
HF communication equipment
Portable HF communications equipment (including peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical
device could result.
The medical device may be interfered by other equipment, even if these other devices comply with CISPR (International
special committee on radio interference) emission requirements.
Use of this medical device adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this medical device and the other equipment should be observed to verify that
they are operating normally.
The medical device is not intended for use in the vicinity of HF surgical devices.