W&H Proxeo Ultra PB-510, Proxeo Ultra PB-530, Proxeo Ultra PB-520 Instructions For Use Manual
Instructions for Use
PB-510, PB-520, PB-530
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
2
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
3
Symbols
in the Instructions for Use
WARNING!
(risk of injury)
4
(to prevent damage occurring)
ATTENTION!
General explanations,
without risk to persons or objects
Symbols
+30°C Max.
on the medical device
25UX
Consult Instructions for Use
XXXX
Follow Instructions for Use
Date of manufacture
Do not dispose of with
domestic waste
for product information
including UDI (Unique
Device Identification)
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.
CE mark
with identification number
of the Notified Body
Foot control
Non-ionizing electromagnetic
radiation
Catalogue number
Serial numberDataMatrix Code
DC – direct current
V
W
Hz
Supply voltage
Electric power consumption
Frequency of the
alternating current
ESI (External System Interface)
Coolant volume
(+86°F)
Upper limit of temperature
5
Symbols
on the foot control
XXXX
CE mark
with identification number
of the Notified Body
Do not dispose of with
domestic waste
DataMatrix Code
for product information
including UDI (Unique
Device Identification)
UL Component Recognition
Mark indicates compliance
with Canadian and
U.S. requirements
IPX1
Non-ionizing electromagnetic
radiation
DC – direct current
Protection against
dripping water
Wireless foot control C-NW
Catalogue number
Serial number
Date of manufacture
Reset
6
Symbols
on the packaging
XXXX
CE mark with identification number
of the Notified Body
This way up
Fragile, handle with care
Keep dry
»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.
8 %
80 %
DataMatrix Code
for product information including UDI
(Unique Device Identification)
Data structure in accordance with
Health Industry Bar Code
+60 °C (+140°F) Max.
Temperature limitation
Humidity limitation
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.
7
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.
8
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.
9
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.
10
The medical device is not intended for use in the vicinity of HF surgical devices.
3. Unpacking
Remove the insert.
Remove the control unit,
the coolant tank and
the foot control.
W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies.
However, we recommend that you keep the original packaging.
Remove the Instructions for
Use and the accessories.
11
4. Scope of delivery
Control unit (100–230 V) PB-510
30323000
REF 02675000 Coolant filter X
REF 05075600 Coolant hose (Ø 6 mm, approx. 2 m) X
REF 08016690 Power supply with adaptor X X X
REF 07991190 Coolant tank X X
REF 08014700 Cable (pairing/charging) X
Optional
REF 30316000 Foot control C-NW
REF 04717300 Foot control C-NF
REF 30326000 Handpiece PB-5 L
REF 30327000 Handpiece PB-5 L Q
REF 30328000 Handpiece PB-5 L S
PB-520
30324000
PB-530
30325000
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5. Safety notes
> 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 and cooling function.
> Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction
(the exception are endodontics applications).
> In case of coolant supply failure, the medical device must be stopped immediately.
The exception to this is in endodontic applications, where coolant is not used.
Maximum operating time without coolant: > 2 minutes for the power range 1–30
> 30 seconds for the power range 31–40
> Perform a test run each time before using.
> Never touch the patient and the electrical contacts on the medical device simultaneously.
> Check the parameter settings every time you restart.
> Make sure that the supply hose is dry. Moisture in the supply hose can lead to a malfunction (risk of short circuit).
> Replace damaged or leaking O-rings immediately.
> Do not twist, kink or squeeze the supply hose (risk of damage).
Control unit/Foot control
13
Safety notes
The medical device is classed as »conventional equipment« (closed equipment without protection against
the ingress of water).
The medical device is not approved for operation in potentially explosive explosive atmospheres.
Disconnect the medical device in dangerous situations from the power supply.
> Pull the power supply out of the socket.
> Only use the cable supplied for the foot control (C-NW).
System failure
A total system failure does not constitute a critical fault.
Pull the power supply out of the socket and then connect again.
Control unit/Foot control
14
Safety notes
Control unit PB-510
> Disconnect the medical device from the water supply connection after each use (the medical device does not have an
automatic aquastop).
> The medical device is approved for use only with supply units with category 5 backflow prevention devices as defined
in EN 1717.
> Do not connect the medical device to the hot water supply (>30°C/86°F).
Control unit PB-520, PB-530
> Never fill or top up the coolant tank with liquids hotter than 30°C/86°F.
> Replace a faulty or leaky pump cartridge immediately.
Control unit PB-510, PB-520, PB-530
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 with cardiac pacemakers.
The control unit is designed for use with the W&H handpiece PB-5 L/L S/L Q so only this is to be used with the control unit.
The use of other handpieces could lead to a malfunction or destruction of the electronics.
Control unit
15
Safety notes
> Keep the foot control (C-NW) away from magnetic fields.
> Replace the foot control as soon as the resistance is noticeably reduced.
> Do not expose the medical device to any violent mechanical impacts.
Battery (C-NW)
> Do not charge the battery unattended.
> As soon as the charging cycles start to deteriorate send the medical device to an authorized W&H service partner.
> Defective or worn-out batteries must only be replaced by an authorized W&H service partner.
> Charge the battery of the foot control as soon as the status LED flashes.
> Incorrect use of the rechargeable battery can cause fire or corrosion.
Foot control
16
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