W&H proxeo TWIST User manual

Instructions for use
PL-40 H

2
Contents
Symbols.......................................................................................................................................................................................................... 4
1. Introduction ............................................................................................................................................................................................... 7
2. Scope of delivery....................................................................................................................................................................................... 9
3. Safety notes ............................................................................................................................................................................................ 10
4. Description............................................................................................................................................................................................... 15
Handpiece drive.................................................................................................................................................................................. 15
Foot control C-NW ............................................................................................................................................................................... 16
Status LED handpiece drive ................................................................................................................................................................17
Status LED foot control....................................................................................................................................................................... 18
5. Start-up .................................................................................................................................................................................................... 19
Charging the battery........................................................................................................................................................................... 19
Query battery status .......................................................................................................................................................................... 20
Pairing ..................................................................................................................................................................................................21
Assembly/removal of the Prophy Angle ............................................................................................................................................ 23
6. Handpiece drive ...................................................................................................................................................................................... 24
Switch on/off....................................................................................................................................................................................... 24
Test run................................................................................................................................................................................................ 25
7. Hygiene and maintenance...................................................................................................................................................................... 26
General notes...................................................................................................................................................................................... 26
Limitations on processing.................................................................................................................................................................. 27
Initial treatment at the point of use .................................................................................................................................................. 28
Manual cleaning.................................................................................................................................................................................. 29
Manual disinfection............................................................................................................................................................................30
Automated cleaning and disinfection ............................................................................................................................................... 31
Drying.................................................................................................................................................................................................. 32
Inspection, Maintenance and Testing................................................................................................................................................ 33
Packaging............................................................................................................................................................................................ 34

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Contents
Sterilization......................................................................................................................................................................................... 35
Storage ................................................................................................................................................................................................ 36
8. Replacing the O-ring................................................................................................................................................................................ 37
9. Servicing .................................................................................................................................................................................................. 38
10. Accessories, consumables, spare parts and other recommended medical devices by W&H........................................................ 40
11. Technical data........................................................................................................................................................................................ 41
12. Data on electromagnetic compatibility according to IEC/EN 60601-1-2.......................................................................................... 44
13. Disposal.................................................................................................................................................................................................. 47
Explanation of warranty terms................................................................................................................................................................... 48
Authorized W&H service partners.............................................................................................................................................................. 49

4
Symbols
Do not dispose of with domestic
waste
WARNING!
(risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations,
without risk to persons or
objects
Follow instructions for use
Manufacturer
Date of manufacture
CE mark
with identification number
of the Notified Body
XXXX
Medical device
Thermo washer disinfectable
Sterilizable
up to the stated temperature
Class II medical
electrical equipment
Not for re-use
2
Non-ionizing electromagnetic
radiation
Catalogue number
Serial number
DC – direct currentNon-sterilizable

5
Symbols
Not suitable for intracardiac
application – Type BF appliance
Data Matrix code
for product information including
UDI (Unique Device Identification)
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
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.
Data structure in accordance with
Health Industry Bar Code
MEDICAL – GENERAL MEDICAL
EQUIPMENT AS TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE
WITH ANSI/AAMI ES60601-
1:2005/(R)2012 + A1:2012 +
C1:2009/(R)2012 + A2:2010/
(R)2012, ANSI/AAMI ES60601-
1:2005/A2:2021, CAN/CSA-C22.2
No. 60601-1:14, CAN/CSA-C22.2
No. 60601-1:14/A2:22, IEC
80601-2-60:2019. 25UX –
Control No.
25UX
Temperature limitation
-20 °C (-4°F) Min.
+60 °C (+140°F)Max.
8 %
80 % Humidity limitation

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Symbols l
RCM – Australian / New Zealand
GITEKI (MIC) – Japan
ANATEL – Brazil
FCC / IC – USA / Canada
R209 - J00204

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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
PL-40 H: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and
fillings.
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”.

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Introduction
Hereby, W&H declares that the medical device 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 49).
> 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!

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2. Scope of delivery
REF Description
30317000 Handpiece drive
07969610 Charger with adaptor
05882600 Handpiece holder
Optional included in set
30316000 Foot control C-NW with Stick

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3. 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.
> 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.