Young INFINITY PL-40 H User manual

Instructions for use

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Contents
Symbols.......................................................................................................................................................................................................4 – 7
1. Introduction........................................................................................................................................................................................ 8 – 9
2. Electromagnetic compatibility (EMC) ..................................................................................................................................................10
3. Package Contents ...................................................................................................................................................................................11
4. Safety notes................................................................................................................................................................................... 12 – 16
5. Description of handpiece........................................................................................................................................................................18
6. Description of foot control......................................................................................................................................................................19
7. Description status LED – Handpiece .................................................................................................................................................... 20
8. Description status LED – Foot control................................................................................................................................................... 21
9. Start-up – Charging the battery ............................................................................................................................................................ 22
10. Start-up – Query battery status.............................................................................................................................................................23
11. Start-up – Pairing........................................................................................................................................................................... 24 – 25
12. Start-up – Attachment & removal of disposable barrier sleeve and doriot style disposable prophy angle ............................. 26 – 27
13. Operation – Handpiece .......................................................................................................................................................................... 28
14. Test run....................................................................................................................................................................................................29
15. Hygiene and maintenance ............................................................................................................................................................30 – 34
16. Replacing the O-ring................................................................................................................................................................................35
17. Young Dental accessories and spare parts.......................................................................................................................................... 36
18. Servicing.........................................................................................................................................................................................37 – 38
19. Technical data ................................................................................................................................................................................39 – 40
20. Disposal...................................................................................................................................................................................................41
Explanation of warranty terms...................................................................................................................................................................... 42
Authorized Young Dental service partners ....................................................................................................................................................43

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Symbols in the instructions for use
WARNING!
(risk of injury)
ATTENTION!
(to prevent damage occurring)
General explanations,
without risk to persons or property
Sterilizable
up to the stated temperature
Thermo washer disinfectable Not for re-use
Call customer service

5
Symbols on the handpiece
Follow instructions for use
Date of manufacture
Article number
Serial number
Data Matrix code
for product information
including UDI (Unique Device
Identification)
Not suitable for intracardiac
application – Type BF
appliance
Do not dispose of with domestic
waste
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.)
Non-ionizing electromagnetic
radiation
Non-sterilizable

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Symbols on the foot control
UL Component Recognition
Mark indicates compliance
with Canadian and
U.S. requirements
Non-ionizing electromagnetic
radiation
Do not dispose of with
domestic waste
Article number
Serial number
Date of manufacture
Data Matrix code
for product information
including UDI (Unique Device
Identification)
DC – direct current
Protection against
dripping water
IPX1
Foot control
cordless C-NW
Reset

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Symbols on the packaging
This way up
Caution! According to U.S. 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 who intends to use or order the
use of this medical device.
Fragile, handle with care
Keep dry
Permitted temperature range
Humidity,
limitation
»Der Grüne Punkt«
(The Green Dot) trademark of Duales
System Deutschland GmbH
Identification of recyclable
transport and outer packaging
of paper and cardboard
-20 °C (-4°F) Min.
+60 °C (+140°F)Max.
8 %
80 %
Data Matrix code
for product information including UDI
(Unique Device Identification)

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1. Introduction
For your safety and the safety of your patients
These instructions provide recommendations for safe operation of the enclosed medical device and are intended to
protect the safety of the operator and patient.
Observe the safety notes on pages 12 to 16.
Intended use and Operational Contexts of Use
Handpiece: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth
surfaces and fillings.
Foot controller: Foot control for operation of medical electrical equipment.
Misuse may damage the medical device and subsequently cause risks and hazards for patients,
users and third parties.
The cordless handpiece was designed for use by dentists, dental hygienists, dental employees (prophylaxis),
and dental assistants.

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Introduction
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device if it is used
in compliance with the following directions:
> The medical device must be used in accordance with these instructions for use.
> The medical device does not have any components that can be repaired by the user. Assembly, modifications or repairs
must only be undertaken by an authorized Young Dental service partner (see page 43).
> 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.

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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.
Young Dental only guarantees compliance of the control unit with the EMC Directives when it is used with
original
Young Dental accessories and spare parts. The use of accessories and spare parts that have not been
approved by Young Dental may lead to increased emission of electromagnetic interference or to reduced
resistance to electromagnetic interference.
You may find current EMC manufacturer declarations at www.youngdental.com
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.

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3. Package Contents
REF Description
29 5721 White Handpiece
295792 Foot Controller incl. Stick
295788 Charger incl. adaptor
295789 Handpiece cradle
295830 Disposable Barrier Sleeve (1 pack of 25 sleeves)
295791 Removable nosecone (3 units - 1 on handpiece and 2 in the box)

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4. Safety notes
> When operating the handpiece, always consider the safety of the patient.
> 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 before every use.
> Do not operate the medical device if it is damaged.
> Replace the foot control as soon as the resistance of the pedal is noticeably reduced.
> Always ensure that the correct operating conditions are provided.
> Perform a test run outside the patient's oral cavity prior to every treatment. If any abnormalities are found, stop using
immediately and contact Young Dental. Abnormalities can include, but are not limited to, vibration, noise, and overheating.
> Always operate the handpiece with fitted nosecone.
> Follow additional manufacturer safety recommendations for the doriot style disposable prophy angle.
> Never touch the patient and the electrical contacts on the medical device simultaneously.
> Keep the foot control away from magnetic fields.
> Should the handpiece function abnormally during use, cease operation immediately and return the handpiece to an
authorized Young Dental service parnter for repair (see page 43).
Battery
> Charge the battery of the handpiece and the foot control as soon as the status LED flashes.
> Do not leave the battery to charge unattended.
> The battery used can pose a risk of fire or chemical burns if it is not used correctly.
> Send the handpiece or foot control to an authorized Young Dental service parnter (see page 43)
for replacement of the battery as soon as the charging cycles start to deteriorate.
> Defective or worn-out batteries must only be replaced by an authorized Young Dental service parnter (see page 43).

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Safety notes
The medical device is classed as »conventional equipment« (closed equipment without protection against the ingress of water).
Charger
> Only use the charger supplied.
System failure
A total system failure does not constitute a critical fault.
Simply switch the unit off and then on again.
Hygiene and maintenance prior to initial use
> Clean and reprocess the handpiece and the foot control.
> Sterilize the handpiece nosecone.
Improper use
In addition to unauthorized assembly or modification of or repairs to the medical device and non-compliance with our
instructions, improper use will invalidate all claims made under warranty or otherwise.

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Safety notes
Danger zones M and G
The medical device is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures
of anaesthetic substances containing oxygen or nitrous oxide according to IEC 60601-1/ANSI/AAMI ES 60601-1.
The medical device is not suitable for use in oxygen-enriched atmospheres.
Zone M is defined as a »medical environment« and constitutes the part of a room in which potentially explosive
atmospheres may form due to the use of anaesthetics or medical antiseptics and antibacterial soaps;
such atmospheres are typically localized and temporary.
Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle.
Zone G, also known as an »enclosed medical gas system«, does not necessarily include areas enclosed around
all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities.

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Safety notes
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.
> Find out if patients and users have an implanted device before using the medical device and test the
possible applications.
> Weigh the risks and benefits.
> Keep the medical device away from implanted devices.
> Take appropriate emergency precautions and take immediate action on any signs of changes to health.
> Symptoms such as increased heartbeat, irregular pulse and dizziness can be signs of a problem with
a cardiac pacemaker or ICD.

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Safety notes
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.

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5. Description of handpiece
Removable nosecone
Coupling for doriot style
disposable prophy angle
ON/OFF button
Charging
socket
Status LED handpiece
(see page 20)
Status LED foot control
(see page 21)

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6. Description of foot control
Charging LED (orange)
(see page 21 - 22)
Status LED (green)
(see page 21, 24)
Reset button Pairing button
Charging socket
Stick

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7. Description status LED – Handpiece
LED illuminates flashes flashes intermittently
GREEN Battery is 25 – 100% charged
Pairing successful
> Handpiece is ready for operation
Pairing active
ORANGE Battery is charging Battery is 2 – 25% charged
> Complete the treatment
> Do not start any further treatment
> Charge the battery
Battery is 1% charged
> Charge the battery
RED Error message
> Contact a Young Dental
service parnter
Standby mode
> The handpiece can be activated with the ON/OFF button.
> If the handpiece is not used for longer than 4 minutes, it returns to standby mode automatically.