Sirona LEDview Manual de usuario
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Operating Instruct ions
62 07 687 D3530
2D3530.201.01.06.02 07.2011
Sirona Dental Systems GmbH
Operating Instructions LEDview / LEDview S
Table of contents
1General information.................................................................................................. 4
1.1 Dear Customer,............................................................................................. 4
1.2 Contact information ....................................................................................... 4
1.3 General information on the Operating Instructions ....................................... 5
1.4 Structure of the document............................................................................. 5
1.4.1 Identification of danger levels............................................................. 5
1.4.2 Formats and symbols used................................................................ 6
1.5 Scope of this operating manual..................................................................... 6
1.6 Warranty and liability..................................................................................... 7
1.7 Intended use ................................................................................................. 7
2Safety information .................................................................................................... 8
2.1 Information on the unit .................................................................................. 8
2.2 Care and cleaning agents ............................................................................. 8
2.3 Trouble-free operation................................................................................... 8
2.4 Blinding ......................................................................................................... 8
2.5 Composite mode ........................................................................................... 8
2.6 Safety checks................................................................................................ 9
2.7 Electromagnetic compatibility........................................................................ 9
2.8 Dismantling/Installation ................................................................................. 9
3Unit description......................................................................................................... 10
3.1 Standards/Approvals..................................................................................... 10
3.2 Technical Data .............................................................................................. 10
3.3 Optional filter disk.......................................................................................... 13
3.4 System overview ........................................................................................... 13
3.4.1 LEDview as unit model....................................................................... 13
3.4.2 LEDview as ceiling model / ceiling combination................................. 15
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Sirona Dental Systems GmbH
Operating Instructions LEDview / LEDview S
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4Operation................................................................................................................. 16
4.1 Operation via the dentist or assistant element ............................................. 16
4.1.1 TENEO.............................................................................................. 16
4.1.2 SINIUS .............................................................................................. 17
4.1.3 M1 ⁺ , C2 ⁺ , C3 ⁺ , C4 ⁺ , C5 ⁺ units .................................................... 18
4.1.4 C8 ⁺ units ........................................................................................... 19
4.1.5 Ceiling model / Ceiling combination .................................................. 19
4.2 Operating the LEDview via the proximity switch .......................................... 20
4.3 Positioning the light field............................................................................... 22
5Care and cleaning instructions for the practice team .............................................. 23
5.1 Basics........................................................................................................... 23
5.2 Care and cleaning agents ............................................................................ 23
5.3 Cleaning and disinfecting lamp components................................................ 24
5.4 Cleaning and disinfecting the handles.......................................................... 24
5.5 Using hygienic protective sleeves ................................................................ 24
6Disposal................................................................................................................... 25
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1 General information Sirona Dental Systems GmbH
1.1 Dear Customer, Operating Instructions LEDview / LEDview S
1General information
General information
1.1 Dear Customer,
Dear Cus tomer,
We are pleased that you have equipped your practice with the LEDview /
LEDview S 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 technical documentation supplied is also part of the product. Always
keep this documentation within reach.
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.
Team information*** not for Japan ****
Your LEDview / LEDview S Team
1.2 Contact information
Contact i nformation
Customer service center Our German and English speaking Product Service staff are ready to
answer your technical questions by telephone from 7:30 a.m. to 5:30 p.m.
CET. Outside of these times, please contact us via fax.
Phone: +49 (0) 6251/16-1670
Fax: +49 (0) 6251/16-1818
Or 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
Manufacturer's address Sirona Dental Systems
Fabrikstrasse 31
64625 Bensheim
Germany
Phone: +49 (0) 6251/16-0
Fax: +49 (0) 6251/16-2591
E-mail: [email protected]
www.sirona.com
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Sirona Dental Systems GmbH 1General information
Operating Instructions LEDview / LEDview S 1.3 General information on the Operating Instructions
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1.3 General information on the Operating Instructions
General information on the Operating Instructions
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.
Keep documents safe Always keep the Operating Instructions handy in case you or another
user require(s) information at a later point in time.
In case you sell the unit, make sure that the Operating Instructions and all
other technical documents are attached to it so that its new owner can
familiarize himself with its functioning and the specified warning and
safety information. The technical documents are a component of the
product.
Help If you reach an impasse despite having thoroughly studied the Operating
Instructions, please contact your dental depot.
1.4 Structure of the document
Structure of the document
1.4.1 Identification of danger levels
Identification of danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in this document. Such
information is highlighted as follows:
Tip: Information on making work easier.
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.
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1 General information Sirona Dental Systems GmbH
1.5 Scope of this operating manual Operating Instructions LEDview / LEDview S
1.4.2 Formats and symbols used
Formats and symbols used
The symbols and character formats used in the present manual have the
following meaning:
1.5 Scope of this operating manual
Scope of this operating man ual
LEDview This document describes the operation of the LEDview operating light as
a unit model, a ceiling model or a ceiling combination with an X-ray tube
assembly.
LEDview S This document describes the operation of the LEDview S operating light
as a unit model.
Use with TENEO, SINIUS, M1+, C2+, C3+, C4+, C5+, and C8+
LEDview unit model The LEDview can be operated as a unit model with the TENEO, SINIUS /
SINIUS CS, M1+, C2+, C3+, C4+, C5+, and C8+ treatment centers. The
LEDview is attached to the lamp support tube of the treatment center. It
is operated via the user interface of the treatment center or the proximity
switch.
LEDview S unit model The LEDview S can be operated as a unit model with the SINIUS /
SINIUS CS treatment center. The LEDview is attached to the lamp
support tube of the treatment center. It is operated exclusively via the
user interface of the treatment center. The maximum brightness can be
set by the service engineer.
Ceiling model As a ceiling model, the LEDview is operated independently of a treatment
center. The LEDview is mounted on the ceiling of the treatment room via
a support arm system. It can be operated only via the proximity switch.
Ceiling combination The LEDview can be operated as a ceiling combination mounted on a
support arm system together with an X-ray tube assembly. The X-ray
tube assembly and the LEDview have separate power supply
connections. The LEDview is operated only via the proximity switch.
✔Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
Requests you to do something.
See "Formats and symbols
used [ → 6]“
Identifies a reference to another
text passage and specifies its page
number.
●List Identifies a list.
"Command/menu item" Identifies commands, menu items
or quotations.
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Sirona Dental Systems GmbH 1General information
Operating Instructions LEDview / LEDview S 1.6 Warranty and liability
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1.6 Warranty and liability
Warranty and liability
Warranty Passport To safeguard your warranty claims, please complete the attached
"Installation Report/Warranty Passport" together with the service
engineer immediately after the installation of your unit.
Maintenance Maintenance must be performed at scheduled intervals to ensure the
operational and functional reliability of your product and to protect the
safety and health of patients, users and other persons. For more
information, please refer to "Maintenance by the service engineer" or
"Inspection and maintenance" in the operating instructions for your
treatment center.
The owner is responsible for making sure that all maintenance activities
are performed.
As manufacturers of medical electrical equipment, we can assume
responsibility for the safety properties of the unit only if maintenance and
repairs on the unit are performed either by us or by agencies which we
have expressly authorized and if components of the unit are replaced by
original spare parts in case of failure.
Exclusion of liability In the event that the system owner fails to fulfill its obligation to perform
maintenance activities or ignores error messages, Sirona Dental Systems
GmbH and its authorized dealers cannot assume any liability for any
damage thus incurred.
1.7 Intended use
Intended use
The operating light is used to illuminate the treatment area during dental
treatment. The light may be used only by trained and qualified personnel.
This device is not intended for operation in areas subject to explosion
hazards.
Proper use also includes compliance with the present operating
instructions and the relevant cleaning and care instructions.
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2 Safety information Sirona Dental Systems GmbH
2.1 Information on the unit Operating Instructions LEDview / LEDview S
2Safety information
Safety informa tion
2.1 Information on the unit
Information o n the unit
One of the two adjacent symbols can be found on the unit rating plate:
● Observe accompanying documents
The accompanying documents are attached to the unit.
2.2 Care and cleaning agents
Care and cleaning agents
Unsuitable care and cleaning agents may corrode the surface of the unit.
Therefore, use only care and cleaning agents which have been approved
by Sirona. For more information, please refer to "Care and cleaning
instructions for the practice team".
2.3 Trouble-free operation
Trouble-fr ee operation
Generally valid
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
Blinding
2.5 Composite mode
Composi te 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.
WARNING
Patients with the very rare (approx. 1: 250,000) condition Xeroderma
pigmentosum must not be treated with the light on full power. You must
consult the dermatologist treating the patient concerned in each case.
IMPORTANT
To prevent premature curing when composite fillings are used, always
operate the light in composite mode under these circumstances. The
brightness is then limited to approx. 8,000 lux. Despite the reduction in
illuminance, 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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Sirona Dental Systems GmbH 2Safety information
Operating Instructions LEDview / LEDview S 2.6 Safety checks
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2.6 Safety checks
Safety checks
Please observe the chapter on "Safety checks" in the operating
instructions for your treatment center.
No safety checks of the LEDview / LEDview S are required for the ceiling
model or the ceiling combination.
2.7 Electromagnetic compatibility
Electromagnetic compatibility
Medical electrical devices are subject to special precautionary measures
with regard to electromagnetic compatibility (EMC). They must be
installed and operated in compliance with the specifications provided for
the respective treatment center 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 practice 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".
2.8 Dismantling/Installation
Dismantling /Installation
Follow the installation instructions
When dismantling and reinstalling the unit, proceed according to the
installation instructions for new installation in order to guarantee its proper
functioning and stability.
Explosion-hazard areas
This unit must not be used in areas subject to explosion hazards.
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3 Unit description Sirona Dental Systems GmbH
3.1 Standards/Approvals Operating Instructions LEDview / LEDview S
3Unit description
Unit description
3.1 Standards/Approvals
Standards /Approval s
The LEDview / LEDview S operating light complies with the following
standards (the list below is not exhaustive):
● IEC 60601-1 (electrical and mechanical safety)
● IEC 60601-1-2 (electromagnetic compatibility)
● ISO 9680 (Operating light1)
Unit model: In connection with the treatment centers approved for this
purpose, this product complies with the provisions of Council Directive 93/
42/EEC of June 14, 1993 concerning medical devices.
Ceiling model / Ceiling combination: The LEDview / LEDview S bears the
CE mark in compliance with the provisions of Council Directive 93/42/
EEC of June 14, 1993 concerning medical devices.
3.2 Technical Data
Technical Data
LEDview
1. No defined method of measuring the color rendering index currently exists for
the LED technology used. (cf.Technical Report CIE 177:2007.) The normatively
required color temperature of < 6300 K can be attained only with the optional filter
disk. A comparison of dental colors is possible only to a limited extent.
0123
Model designation: LEDview
Light source: 4 light-emitting diodes
Illuminance: adjustable from < 8,000 lux to > 27,000 lux
acc. to ISO 9680
Lighting control: Electronic brightness control, composite
function
Color temperature: 5,700 K – 6,900 K
with optional filter disk: 5,100 K – 5,700 K
Unit model power
connection:
Electrical supply via the treatment center
Line voltage for ceiling
models:
230 V 50 Hz
115, 100 V 60 Hz
Nominal current for
ceiling models:
for 230 V 0.1 A
for 115 V 0.2 A
for 100V 0.23A
Overvoltage category: 2 acc to. IEC 60664-1
Power consumption of
operating light:
< 20 W
Protection class: The unit supplying power corresponds to
protection class I
Degree of protection
against ingress of water:
Ordinary equipment (IPX 0 – without
protection against ingress of water)
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