Dentsply Sirona LEDview Plus User manual

New as of:
Operating Instructions
01.2018
LEDview Plus
English
=
Operating Instruct ions

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Dentsply Sirona Table of contents
Operating Instructions LEDview Plus
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Table of contents
1General information................................................................................................. 5
1.1 Dear Customer,............................................................................................ 5
1.2 Contact information ...................................................................................... 5
1.3 General information about this operating manual ........................................ 6
1.4 Structure of the document............................................................................ 7
1.4.1 Identification of the danger levels.................................................... 7
1.4.2 Formats and symbols used ............................................................. 7
1.5 Scope of this operating manual.................................................................... 8
1.6 Warranty and liability.................................................................................... 8
1.7 Intended use................................................................................................. 8
1.8 Indication and Contraindication.................................................................... 9
2Safety information.................................................................................................... 10
2.1 Information on the unit.................................................................................. 10
2.2 Care, cleaning, and disinfecting agents ....................................................... 10
2.3 Trouble-free operation.................................................................................. 10
2.4 Blinding......................................................................................................... 10
2.5 Composite mode .......................................................................................... 10
2.6 Shade selection of dental restorative materials............................................ 11
2.7 Mechanical stability ...................................................................................... 11
2.8 Modifications and extensions to the device.................................................. 11
2.9 Safety checks............................................................................................... 11
2.10 Electromagnetic compatibility....................................................................... 11
2.11 Dismantling/Installation ................................................................................ 12
3Unit description........................................................................................................ 13
3.1 Standards/Approvals .................................................................................... 13
3.2 Technical data.............................................................................................. 14
3.3 System overview .......................................................................................... 17
3.3.1 LEDview Plus as a unit model......................................................... 17
3.3.2 LEDview Plus as a ceiling light / ceiling combination ...................... 20
4Operation................................................................................................................. 21
4.1 Overview of usage options........................................................................... 21
4.2 Operation via the dentist or assistant element ............................................. 22
4.2.1 Teneo .............................................................................................. 22
4.2.2 Sinius............................................................................................... 24

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Table of contents Dentsply Sirona
Operating Instructions LEDview Plus
4.2.3 Intego ............................................................................................... 26
4.3 Operation via contactless sensor or integrated keyboard ............................. 29
4.3.1 Operation via contactless sensor ..................................................... 29
4.3.2 Operation via the integrated keyboard ............................................. 31
4.4 Positioning the light field ............................................................................... 34
4.5 Accessories for the operating light ................................................................ 35
4.5.1 General information on the accessory interface............................... 35
4.5.2 Patient mirror.................................................................................... 36
4.5.3 Camera holder ................................................................................. 37
5Care and cleaning instructions for the practice team ............................................... 41
5.1 General information....................................................................................... 41
5.2 Basics............................................................................................................ 41
5.3 Care, cleaning agents, and disinfectants ...................................................... 42
5.4 General processing instructions.................................................................... 42
5.5 Inspection, maintenance and testing............................................................. 43
5.6 Cleaning and disinfecting lamp components................................................. 43
5.7 Clean and disinfect the handle sleeves......................................................... 44
5.8 Remove/attach handle sleeves ..................................................................... 45
5.9 Cleaning and disinfecting lamp accessories ................................................. 46
6Malfunctions ............................................................................................................. 47
6.1 The operating light automatically reduces brightness ................................... 47
6.2 The treatment light automatically shuts down ............................................... 47
6.3 Sensor control is not responding to hand movements. ................................. 48
7Disposal.................................................................................................................... 49

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Dentsply Sirona 1General information
Operating Instructions LEDview Plus 1.1Dear Customer,
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1General information
1.1 Dear Customer,
We are pleased that you have equipped your practice with the LEDview
Plus operating light.
You now have a light that features LED technology. It is characterized by
high illuminance, lamp longevity and a lower energy consumption. Its
mechanical adjustability in 3 axes ensures optimal positionability. The
high light quality allows hard tooth tissue and oral mucosa to be displayed
naturally.
Please perform maintenance and cleaning based on the corresponding
instructions.
Familiarize yourself with the lamp by reading these Operating Instructions
before putting it into operation.
It is important to observe all safety information to prevent personal injury
and material damage.
1.2 Contact information
Customer service center In the event of technical queries, please use our online contact form at
www.sirona.com. In the navigation bar, go to the menu commands
"CONTACT" / "Customer Service Center" and then click the "CONTACT
FORM FOR TECHNICAL QUESTIONS"
button.
Manufacturer's address
Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: [phone]
Fax: [phone]
e-mail: [email protected]
www.sirona.com

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1General information Dentsply Sirona
1.3General information about this operating manual Operating Instructions LEDview Plus
1.3 General information about this operating manual
Observe the Operating Instructions Please familiarize yourself with the unit by reading through these
Operating Instructions before putting it into operation. It is essential that
you comply with the specified warning and safety information.
Always keep the operating instructions handy in case you or another user
require(s) information at a later point in time. Save the operating
instructions on the PC or print them out.
If you sell the unit, make sure that the operating instructions are included
with it either as a hard copy or on an electronic storage device so that the
new owner can familiarize himself with its functions and the specified
warning and safety information.
Online portal for technical documents We have set up an online portal for the Technical Documents at http://
www.dentsplysirona.com/manuals. There, you can download these
operating instructions and further documents. Please complete the online
form if you would like a hard copy of a particular document. We will then
be happy to send you a printed copy free of charge.
Help If you require additional help despite having thoroughly studied the
Operating Instructions, please contact your dental depot.

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Dentsply Sirona 1General information
Operating Instructions LEDview Plus 1.4Structure of the document
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1.4 Structure of the document
1.4.1 Identification of the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in these operating instructions.
Such information is highlighted as follows:
Tip: Information for simplifying work.
1.4.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily injury
or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the product
or an object in its environment.
IMPORTANT
Application instructions and other important information.
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢Individual action step
Prompts you to do something.
See “Formats and symbols
used [ → 7]”
Identifies a reference to another text
passage and specifies its page
number.
● List Designates a list.
“Command / menu item” Indicates commands, menu items or
quotations.

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1General information Dentsply Sirona
1.5Scope of this operating manual Operating Instructions LEDview Plus
1.5 Scope of this operating manual
This document describes the operation of the LEDview Plus operating
light as a unit model in the treatment center or as a ceiling light on the
ceiling model (international product name: Ceiling Model).
Unit model The LEDview Plus can be operated as a unit model with the Teneo, Sinius
range and Intego range treatment centers. The LEDview Plus is attached
to the lamp support tube of the treatment center. It is operated via the user
interface of the treatment center and the proximity sensor.
Ceiling model The ceiling model is a ceiling-mounted support arm system for the
LEDview Plus ceiling light or the ceiling combination, consisting of
LEDview Plus and an X-ray tube assembly.
Ceiling light As a ceiling light, the LEDview Plus is operated on the ceiling model
independently of a treatment center. It is operated via the contactless
sensor or the integrated keyboard.
Ceiling combinations As a ceiling combination the LEDview Plus ceiling light is operated on the
ceiling model together with the Heliodent Plus X-ray tube assembly. The
LEDview Plus ceiling light is operated via the contactless sensor or the
integrated keyboard. Operating instructions for the Heliodent Plus can be
found in the separate operating manual for the X-ray unit.
1.6 Warranty and liability
Maintenance In the interest of the safety and health of patients, users or third parties,
it is necessary that maintenance work is carried out at fixed time intervals
to ensure the operational safety and reliability of your product. For more
information, please refer to the section "Safety-related tests" [ → 11].
The operator must ensure the implementation of the maintenance work.
As a manufacturer of electro-medical equipment, we can consider
ourselves responsible for the safety characteristics of the device only if
maintenance and repairs are carried out only by us or by companies
authorized explicitly by us for this purpose and if components are
replaced with original spare parts in case of failure.
Exclusion of liability If the operator does not meet the obligation to carry out such maintenance
or fault messages are ignored, Sirona Dental Systems or its authorized
dealer does not assume any liability for damage caused.
1.7 Intended use
The operating light is designed for illumination of the treatment area and
may only be used by trained dental personnel.
The operating light is not intended for use in potentially explosive
environments.
Use in accordance with the intended purpose also includes compliance
with the operating instructions.

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Dentsply Sirona 1General information
Operating Instructions LEDview Plus 1.8Indication and Contraindication
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1.8 Indication and Contraindication
Indication
● Illumination of the work area in connection with:
– prophylactic treatments
– conservative treatments (cariology and filling therapy,
endodontics)
– periodontal treatments
– oral and maxillofacial surgery
– prosthetic treatments
– orthodontic treatments
– other aspects of dental work
Note: Patients who have the following conditions will not be
negatively affected by the surgical lighting because the LEDs used do
not generate any radiation in the UVA or UVB range:
– actinic prurigo (AP)
– hydroa vacciniforme
– lupus erythematosus (LE)
– xeroderma pigmentosum (XP)
Contraindication
Contraindications of the following parts of dentistry:
● Patients who have one of the following conditions may only be treated
using the lowest possible light intensity. Clarification with the treating
dermatologist must be sought in the individual case.
– chronic actinic dermatitis (CAD)
– polymorphous light eruption (PLE/PMLE)
– cutaneous porphyria
– solar urticaria
● Patients who are taking the following medications have increased
photosensitivity. These patients should be treated with the lowest
possible light intensity. Clarification with the treating physician must
be sought in the individual case.
– Amiodarone at high doses
– photofrin
– foscan
– other medications used for photodynamic treatment (PDT)
● Users with existing age-related macular degeneration (AMD) or a
predisposition to AMD should always work using the lowest possible
(still adequate) brightness level. The light must also be operated with
the lowest possible color temperature setting to keep the blue light
fraction as small as possible.

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2Safety information Dentsply Sirona
2.1Information on the unit Operating Instructions LEDview Plus
2Safety information
2.1 Information on the unit
Accompanying documents
This symbol can be found on the rating plates on the units.
Meaning: Observe the Operating Instructions when operating the unit.
This symbol can be found on the rating plates on the units.
Meaning: The accompanying documents are available on the
manufacturer's homepage.
2.2 Care, cleaning, and disinfecting agents
Unsuitable care and cleaning agents or disinfectants may corrode the
surface of the unit or impair its functioning.
Therefore, use only care and cleaning agents and disinfectants which
have been approved by the manufacturer. For more information, see the
chapter "Care, cleaning, and disinfecting agents".
2.3 Trouble-free operation
Use of this system is permissible only if it works properly without
malfunctions. If trouble-free operation cannot be ensured, the unit must
be taken out of service, checked by authorized technicians for
malfunctions and, if necessary, repaired.
2.4 Blinding
2.5 Composite mode
WARNING
Due to the extreme brightness of the LED technology employed,
directing the light beam into the patient's or user's eyes should be
avoided! Briefly looking into the light beam is harmless.
CAUTION
To prevent premature curing when composite materials are used,
always operate the light in composite mode under these circumstances.
The irradiance based on the spectral sensitivity of the camphorquinone
is < 3 W/m² in accordance with ISO 9680:2014. Despite the reduction in
irradiance, modern high-sensitivity composite materials in particular can
cure prematurely as a result of other light sources, e.g. cap lamps,
ceiling lamps, daylight, etc. The application procedure must, therefore,
be checked on an individual basis.

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Dentsply Sirona 2Safety information
Operating Instructions LEDview Plus 2.6Shade selection of dental restorative materials
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2.6 Shade selection of dental restorative materials
2.7 Mechanical stability
2.8 Modifications and extensions to the device
Modifications to this unit which might affect the safety of the system
owner, patients or other persons are prohibited by law.
For reasons of product safety, this product may be operated only with
original accessories from the manufacturer or third-party accessories
expressly approved by the manufacturer. The user is responsible for any
damage resulting from the use of non-approved accessories.
2.9 Safety checks
Please observe the chapter on "Safety-related tests" in the operator
manual for your treatment center.
No safety-related tests of the LEDview Plus are required for the ceiling
light or the ceiling combination.
Note: Please observe the document "Inspection, maintenance and
safety-related tests" for Heliodent Plus.
2.10 Electromagnetic compatibility
Medical electrical equipment is subject to special precautionary
measures with regard to electromagnetic compatibility (EMC). It must be
installed and operated in compliance with the specifications provided for
the respective treatment center or ceiling model in the document
"Installation Requirements".
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless
phones in medical office or hospital environments must be prohibited.
To ensure safe operation from the standpoint of EMC, please observe the
chapter entitled "Electromagnetic compatibility" in the document
"Installation Requirements".
IMPORTANT
The shade selection of dental restorative materials should be carried out
in daylight.
CAUTION
Only accessories approved by the manufacturer may be attached to the
light crown (see "Accessories for the operating light" [ → 35]). No other
additional attachments are permitted on the support arm system or on
the light crown.

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2Safety information Dentsply Sirona
2.11Dismantling/Installation Operating Instructions LEDview Plus
2.11 Dismantling/Installation
When dismantling and reinstalling the unit, proceed according to the
installation instructions for new installation in order to guarantee its proper
functioning and stability.
This unit must not be used in areas subject to explosion hazards.

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Dentsply Sirona 3Unit description
Operating Instructions LEDview Plus 3.1Standards/Approvals
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3Unit description
3.1 Standards/Approvals
The LEDview Plus operating light and the ceiling model with LEDview
Plus comply with the following standards (the list below is not exhaustive):
● IEC 60601-1 (Electrical and Mechanical Safety)
● IEC 60601-1-2 (Electromagnetic Compatibility)
● IEC 60601-1-6 / IEC 62366 (Usability)
● IEC 62304 (Software Process)
● ISO 9680 (Operating Light)
● IEC 62471 (Photobiological Safety of Lamps and Lamp Systems)
● ISO 17664 (Sterilization of Medical Products)
The operating light and ceiling model with LEDview Plus bear the CE
mark in compliance with the provisions of Council Directive 93/42/EEC of
June 14, 1993 concerning medical devices.
Note: The Heliodent Plus X-ray tube assembly (category IIb) bears a
separate CE mark with the no. of the notified body (0123). This CE mark
is affixed to the wall adapter.
The operating light and ceiling model fulfill the requirements of the
Directive on the Restriction of Hazardous Substances, 2011/65/EU.
This LEDview Plus operating light has been tested by the VDE Testing
and Certification Institute for compliance with the standards.
This ceiling model with LEDview Plus has been tested by the VDE Testing
and Certification Institute for compliance with the standards.
The operating light and ceiling model meet the requirements in
accordance with CAN/CSA- C22.2 No. 60601-1 and AAMI/ANSI ES
60601-1.
LEDview® is a registered trademark of Sirona Dental Systems GmbH.

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3Unit description Dentsply Sirona
3.2Technical data Operating Instructions LEDview Plus
3.2 Technical data
Model designation: LEDview Plus
Unit model power
connection:
Electrical supply via the treatment center.
The operating light is intended for operation
exclusively on the Teneo, Sinius range and
Intego range treatment centers.
Supply for the light with
the unit model:
36 VDC - 1.0 A
24 VDC - 1.5 A
Ceiling model supply for
LEDview Plus:
100 VAC - 240 VAC, 50/60 Hz
0.65 A - 0.4 A
Light source: 4 Multicolor LEDs
Illuminance
(nominal value):
7 adjustment levels
5000 lux, 10000 lux, 15000 lux, 20000 lux,
25000 lux, 30000 lux, 40000 lux
Illuminance in Composite
mode:
approx. 10000 lux
Lighting
settings:
Brightness and color temperature adjustable
independently of each other,
Composite function acc. to ISO 9680:2014
Color temperature
(nominal value):
3 adjustment levels
Level 1: 4600 K,
Level 2: 5400 K,
Level 3: 6200 K
Color temperature in
Composite mode:
3250 K
Color rendering index
(CRI):
>90
Photobiological safety
acc. to IEC 62471:
Risk group 2 - the operating light does not
pose a hazard due to aversion response to
bright light.

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Dentsply Sirona 3Unit description
Operating Instructions LEDview Plus 3.2Technical data
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Light field size: Approx. 200 mm x 100 mm at distance of
700 mm, measured from the light emission
area of the light
Light distribution The following image shows the light
distribution at 40000 lux.
Area A: min. 75% illuminance according to ISO 9680 standard
Area B: min. 50% illuminance according to ISO 9680 standard
75% / 50% / 10%: Measured illuminance with the LEDview Plus
operating light
Protection class: Unit model: The unit supplying power to the
LEDview Plus corresponds to protection
class I
Ceiling model: Class I equipment
Device class in
accordance with Directive
93/42/EEC:
LEDview Plus: Class I equipment
Ceiling model with LEDview Plus: Class I
equipment
Degree of protection
against ingress of water:
Ordinary equipment (IP X0 – without
protection against ingress of water)
Operating mode: Continuous operation
Transport and storage
conditions:
Temperature: -40 °C – +70 °C
(-40 °F – +158 °F)
Relative humidity: 10 % - 95 %
Air pressure: 50 kPa – 106 kPa
Operating conditions: Ambient temperature: 10°C – 35°C
(50 °F – 95 °F)
Relative humidity: 30 % - 85 %
no condensation
Air pressure: 70 kPa – 106 kPa
Installation location: ≤ 3,000 m above sea
level

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3Unit description Dentsply Sirona
3.2Technical data Operating Instructions LEDview Plus
Date of manufacture:
On the type plate of the operating light and
the ceiling model
Dimensions of light
crown:
Dimensions of ceiling
model:
The dimensions of the ceiling model can be
found in the document "Installation
Requirements" for the ceiling model.

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Dentsply Sirona 3Unit description
Operating Instructions LEDview Plus 3.3System overview
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3.3 System overview
The LEDview Plus is fastened to a height-adjustable support arm system.
The LEDview Plus can be easily adjusted with the handgrips to illuminate
the treatment area. Brakes in the support arm hold the LEDview Plus in
the position to which it has been adjusted. The clearly restricted light field
illuminates the treatment area without blinding the patient.
3.3.1 LEDview Plus as a unit model
LEDview Plus on Teneo

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3Unit description Dentsply Sirona
3.3System overview Operating Instructions LEDview Plus
LEDview Plus on the Sinius range (Sinius shown with shifting track)

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Dentsply Sirona 3Unit description
Operating Instructions LEDview Plus 3.3System overview
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LEDview Plus on the Intego range (Intego TS shown)

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3Unit description Dentsply Sirona
3.3System overview Operating Instructions LEDview Plus
3.3.2 LEDview Plus as a ceiling light / ceiling combination
LEDview Plus as a ceiling combination with a Heliodent Plus X-ray tube
assembly
For information regarding operation of the Heliodent Plus X-ray unit,
please refer to the relevant operator manual.