W&H proxeo TWIST PL-40 H User manual

Instructions for use
PL-40 H

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 8
2. Electromagnetic compatibility (EMC)................................................................................................................................................... 10
3. Scope of delivery..................................................................................................................................................................................... 11
4. Safety notes .............................................................................................................................................................................................12
5. Description................................................................................................................................................................................................17
Handpiece drive...................................................................................................................................................................................17
Foot control......................................................................................................................................................................................... 18
Status LED handpiece drive ............................................................................................................................................................... 19
Status LED foot control....................................................................................................................................................................... 20
6. Start-up .....................................................................................................................................................................................................21
Charging the battery............................................................................................................................................................................21
Query battery status ..........................................................................................................................................................................22
Pairing ................................................................................................................................................................................................. 23
Assembly/removal of the Prophy Angle ............................................................................................................................................ 25
7. Handpiece drive ...................................................................................................................................................................................... 26
Switch on/off....................................................................................................................................................................................... 26
Test run................................................................................................................................................................................................ 27
8. Hygiene and maintenance...................................................................................................................................................................... 28
General notes...................................................................................................................................................................................... 28
Limitations on processing.................................................................................................................................................................. 29
Initial treatment at the point of use .................................................................................................................................................. 30
Manual cleaning.................................................................................................................................................................................. 31
Manual disinfection............................................................................................................................................................................ 32
Automated cleaning and disinfection ............................................................................................................................................... 33
Drying.................................................................................................................................................................................................. 34
Inspection, Maintenance and Testing................................................................................................................................................ 35

3
Contents
Packaging............................................................................................................................................................................................ 36
Sterilization......................................................................................................................................................................................... 37
Storage ................................................................................................................................................................................................ 38
9. Replacing the O-ring................................................................................................................................................................................ 39
10. Servicing ................................................................................................................................................................................................ 40
11. W&H Accessories and spare parts....................................................................................................................................................... 42
12. Technical data........................................................................................................................................................................................ 43
13. Disposal..................................................................................................................................................................................................46
Explanation of warranty terms................................................................................................................................................................... 47
Authorized W&H service partners.............................................................................................................................................................. 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
Call customer service
in the instructions for use

5
Symbols
Follow instructions for use Non-sterilizable Catalogue number
Serial number
Data Matrix code
for product information
including UDI (Unique Device
Identification)
Not suitable for intracardiac
application – Type BF appliance
Sterilizable
up to the stated temperature
Do not dispose of with domestic
waste
Thermo washer disinfectable
Date of manufacture
The medical device with reference to electrical safety, mechanical safety
and fire prevention conforms to UL 60601-1:2006,
CAN/CSA-C22.2 No.601.1-M90:2005, CAN/CSA-C22.2 No. 60601-1:2008,
ANSI/AAMI ES 60601-1:2005 25UX (Control No.)
CE mark
with identification number
of the Notified Body
XXXX
on the handpiece drive / handpiece sleeve
Non-ionizing electromagnetic
radiation
DC – direct current

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

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
Data Matrix code
for product information including UDI
(Unique Device Identification)
on the packaging

8
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 H: 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«.

9
Introduction
Production according to EU Directive
The handpiece drive 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).
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 48).
> 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.

10
2. Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions with 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.
You can find the current EMC manufacturer’s declaration on our website at http://wh.com
or request a copy directly from the manufacturer.
HF communication equipment
Do not use any portable and mobile HF communication equipment (e.g., mobile telephones) during operation.
These may affect medical electrical equipment.
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.

11
3. Scope of delivery
REF Description
30317000 Handpiece drive
30316000 Foot control C-NW with Stick
07969610 Charger with adaptor
05882600 Handpiece holder

12
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 that the correct operating conditions are provided.
> Perform a test run each time before using.
> Never touch the patient and the electrical contacts on the medical device simultaneously.
> Only put the medical device into operation when the handpiece sleeve is attached.
> 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.
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

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 atmospheres.
Charger
> Only use the charger supplied.
Hygiene and maintenance prior to initial use
> Clean and disinfect the medical device.
> Sterilize the handpiece sleeve.
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

14
Safety notes Handpiece drive / Foot control
Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD)
can be affected by electric, magnetic and electromagnetic fields. This medical device complies with the reference values
defined in EN 50527-2-1/2016 for unipolar and bipolar pacemakers and is therefore suitable for patients with pacemakers.
> Find out if patient and user have implanted systems before using the medical device and consider the application.
> Keep a safe distance of at least 7 cm between the medical device and the cardiac pacemakers.
> 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.

15
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.

16
Safety notes
The Prophy Angles are disposable articles.
> Use only Prophy Angles which are in perfect condition. Follow the operating instructions of the manufacturer.
> Insert the Prophy Angle only when the medical device is stationary.
> Never touch the Prophy Angle while it is still rotating.
> Only use Prophy Angles with plastic shanks for the Doriot system.
Prophy Angles with metal shanks damage the clamping chuck system.
2
Prophy Angle

17
5. Description Handpiece drive
ON/OFF button
Handpiece sleeve
Charging
socket
Coupling for
Prophy Angle
Nose
Status LED handpiece drive
(see page 19)
Status LED foot control
(see page 20)

18
Description Foot control
Charging LED (orange)
(see page 20 - 21)
Status LED (green)
(see page 20, 23)
Reset button Pairing button
Charging socket
Stick

19
Description Status LED handpiece drive
LED steady flashes flashes intermittently
GREEN eBattery is 25–100 % charged
ePairing successful
> Handpiece drive is ready for
operaion
ePairing active
ORANGE eBattery is charging 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.

20
Description Status LED foot control
LED flashes flashes alternately
ORANGE eBattery of foot control is flat
> Complete the treatment
> Charge the battery of the foot control
ePairing unsuccessful
> Troubleshooting with pairing problems
(see page 23)
* The LED flashes for 40 milliseconds every 4 seconds
Standby mode
> The foot control can be activated by pressing.
LED steady steady flashes flashes intermittently*
GREEN eConnection to paired
medical device
established
eFoot control is attempting
to establish a connection to
the paired medical device
eBattery is flat
> Charge the battery
ORANGE eBattery is charging