W&H proxeo TWIST PL-40 HW User manual

Instructions for use
PL-40 HW

2
Contents
1. Introduction ............................................................................................................................................................................................... 9
2. Electromagnetic compatibility (EMC) .................................................................................................................................................. 11
3. Scope of delivery......................................................................................................................................................................................12
4. Safety notes .............................................................................................................................................................................................13
5. Description............................................................................................................................................................................................... 18
Handpiece drive.................................................................................................................................................................................. 18
Foot control......................................................................................................................................................................................... 19
Status LED handpiece drive ............................................................................................................................................................... 20
Status LED foot control........................................................................................................................................................................21
6. Start-up ....................................................................................................................................................................................................22
Charging the battery........................................................................................................................................................................... 22
Query battery status .......................................................................................................................................................................... 23
Pairing ................................................................................................................................................................................................. 24
Assembly/removal of the handpiece-/contra-angle head ............................................................................................................... 26
7. Handpiece drive ...................................................................................................................................................................................... 27
Operation ............................................................................................................................................................................................. 27
8. Hygiene and maintenance...................................................................................................................................................................... 29
General notes...................................................................................................................................................................................... 29
Limitations on processing..................................................................................................................................................................30
Initial treatment at the point of use .................................................................................................................................................. 31
Manual cleaning.................................................................................................................................................................................. 32
Manual disinfection............................................................................................................................................................................ 33
Automated cleaning and disinfection ............................................................................................................................................... 34
Drying.................................................................................................................................................................................................. 35
Inspection, Maintenance and Testing................................................................................................................................................ 36

3
Contents
9. Replacing the O-ring................................................................................................................................................................................ 37
10. Servicing ................................................................................................................................................................................................ 38
11. W&H Accessories and spare parts....................................................................................................................................................... 40
12. Technical data........................................................................................................................................................................................42
13. Disposal.................................................................................................................................................................................................. 45
Explanation of warranty terms................................................................................................................................................................... 46
Authorized 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
Not for re-use
2
in the instructions for use
Thermo washer disinfectableSterilizable up to
the stated temperature
Class II medical
electrical equipment

5
Symbole
Follow instructions for use
Non-sterilizable
Catalogue number
Serial number
Data Matrix code
for product information
including UDI (Unique Device
Identification)
Type BF applied part (not
suitable for intracardiac
application)
Do not dispose of with
domestic waste
Date of manufacture
CE mark
with identification number
of the Notified Body
XXXX
on the handpiece drive
Non-ionizing electromagnetic
radiation
DC – direct current
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

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
Data Matrix code
for product information
including UDI (Unique Device
Identification)
CE mark
with identification number
of the Notified Body
XXXX
Foot control
cordless C-NW
on the foot control
Reset
Manufacturer

7
Symbols radio symbol on the medical device / foot control
RCM – Australian / New Zealand
GITEKI (MIC) – Japan
RANATEL – Brazil
FCC / IC – USA / Canada
209 - J00204

8
Symbols
This way up
Caution! According to Federal law restricts this
device to sale by or on the order of a physician,
dentist, 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.
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
Data Matrix code
for product information including UDI
(Unique Device Identification)
on the packaging
Date of manufacture

9
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
PL-40 HW: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and
fillings.
C-NW: Foot control for operation of medical electrical equipment.
Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties.
Qualifications of the user
We have based our development and design of the medical device on the target group “dentist, dental hygienist, dental employees
(prophylaxis) and dental assistants”.

10
Introduction
Hereby, W&H declares that the foot control is in compliance with Directive 2014/53/EU (RED).
The full text of the EU declaration of conformity is available at the following internet address https://wh.com
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).
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 47).
> The foot control 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.
Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the
competent authority!

11
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 (11.8 inch) 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.

12
3. Scope of delivery
REF Description
30410000 Handpiece drive
30316000 Foot control C-NW with Stick
07969610 Charger with adaptor
05882600 Handpiece holder

13
4. 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.
> Perform a test run each time before using.
> Never touch the patient and the electrical contacts on the medical device simultaneously.
> Keep the foot control 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.
> The handpiece drive must not be disassembled.
Battery
> 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 medical device as soon as the status LED flashes.
> Incorrect use of the rechargeable battery can cause fire or corrosion.
Handpiece drive / Foot control

14
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 atmospheres.
Charger
> Only use chargers approved by W&H.
Hygiene and maintenance prior to initial use
> Clean and disinfect the handpiece drive and the foot control.
System failure
A total system failure does not constitute a critical fault.
Simply switch the unit off and then on again.
Handpiece drive / Foot control

15
Safety notes Handpiece drive / Foot control
Handpiece drive
Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD)
can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with
unipolar and bipolar pacemakers or ICD, if a safety distance between the medical device and the cardiac pacemaker or ICD
of at least 7 cm (2,76 inch) is maintained.
> Find out if patient or user have implanted systems before using the medical device and consider the application.
> Weigh the risks and benefits.
> Make appropriate emergency precautions 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.
Foot control
> Keep the foot control away from implanted systems.

16
Safety notes Handpiece drive / Foot control
1,83 m
2,5 m
1,83 m1,83 m
The patient environment (see diagram) encompasses the area up to
2.50 m above the patient and 1.83 m in all horizontal directions.
The charger must not be used within
the patient environment.

17
Safety notes
> Use only the handpiece drive with the handpiece-/contra-angle head PL-44, PL-66 W, PL-64.
> Follow the directions and safety notes in the Instructions for Use of the handpiece-/contra-angle head.
Handpiece-/contra-angle head

18
5. Description Handpiece drive
ON/OFF button
W&H coupling for
handpiece-/contra-angle head
Charging
socket
Status LED handpiece drive
(see page 20)
Status LED foot control
(see page 21)

19
Description Foot control
Charging LED (orange)
(see page 21 – 22)
Status LED (green)
(see page 21, 24)
Reset button Pairing button
Charging socket
Stick

20
Description Status LED handpiece drive
LED steady flashes flashes intermittently
GREEN eBattery is 25–100 % charged
ePairing successful
> Handpiece drive is ready for
operation (charging cable must
be disconnected)
ePairing active
ORANGE eBattery is charging
> Not ready for operation
eBattery is 2–25 % charged
> Complete the treatment
> Do not start any further treatment
> Charge the battery
eBattery is 1 % charged
> Charge the battery
RED eError message
> Contact an authorised W&H
service partner
Standby mode
> The handpiece can be activated with the ON/OFF button.
> If the handpiece drive is not used for longer than 4 minutes, it returns to standby mode automatically.