Sirona Dental Systems GmbH1 General information
Operating Instructions SINIUS / SINIUS CS1.1 Dear Customer,
General information
1
General information
1.1
1.2
Customer service centerOur German and English speaking Product Service staff are ready to
Dear Customer,
Dear Customer,
We are pleased that you have equipped your practice with the Sirona
®
SINIUS / SINIUS CS
Our aim is to recognize our customers' demands in good time and to
create innovative solutions. Together with your trade partner, you have
configured the unit to suit your individual tastes. The new hub of your
treatment room is tailored to your personal needs.
With SINIUS / SINIUS CS
stands for easy operation, innovative comfort and high quality design.
With SINIUS / SINIUS CS
turned customer requirements into innovations. The EasyTouch user
interface makes treatment even more pleasant and efficient.
These Operating Instructions are designed to assist you prior to initial use
and whenever you require information later on.
We wish you a great deal of success and pleasure with SINIUS / SINIUS
®
.
CS
Your SINIUS / SINIUS CS
treatment center.
®
you have chosen a treatment center that
®
we have enhanced proven functions and
®
team
Contact information
Contact information
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.
1.3 Notes on these Operating InstructionsOperating Instructions SINIUS / SINIUS CS
1.3
Notes on these Operating Instructions
Notes on these Operati ng Instructions
1.3.1General information on the Operating Instructions
General information on the Operating Instructions
Observe the Operating InstructionsPlease 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.
Tip: A quick guide containing brief operating instructions has been
provided to help you look up functions quickly.
Keep documents safeAlways 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.
Should you subsequently sell the unit, ensure that the DVD containing the
user documentation is included with the unit so that the new owner can
be suitably informed about the function of the unit and the warning and
safety information provided.
How to order documentsOur Customer Service Center can provide the operating instructions in
paper format free of charge on request. Please state the product name/
type number, and serial number of your unit (see contact details). The
latest documentation can always be downloaded from the Sirona
homepage (http://td.sirona.com).
HelpIf you reach an impasse despite having thoroughly studied the Operating
Instructions, please contact your dental depot.
1.3.2Scope of these Operating Instructions
System versionsThese Operating Instructions apply to the following treatment centers:
Equipment optionsThis document describes the full version of your system. It may therefore
FirmwareThis document is valid for systems with software versions from:
Scope of these Operating Instructions
● SINIUS (Dentist element with travel track)
● SINIUS CS (Dentist element with swivel arms)
cover components that are not included in the system you purchased.
Software version 1.0
Version 1.0
The current software version is displayed in the setup, see "Opening
Setup programs" [ → 157].
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Sirona Dental Systems GmbH1 General information
Operating Instructions SINIUS / SINIUS CS1.4 Other valid documents
1.4
1.5
Warranty PassportTo safeguard your warranty claims, please complete the attached
MaintenanceMaintenance must be performed at scheduled intervals to ensure the
Other valid documents
Other valid documents
Your treatment center can be equipped with additional components that
are described in separate sets of operating instructions. The instructions
as well as any warning and safety information contained therein also must
be observed.
A separate manual of operating instructions exists for each of the
following Sirona products:
HUGO, CARL and PAUL
● Treatment instruments and accessories
● Operating lightLEDview / LEDview S
● 22" flat screen monitor
● HUGO, CARL and PAUL dental working stools
Warranty and liability
Warranty and liability
"Installation Report/Warranty Passport" together with the service
engineer immediately after the installation of your unit.
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" [ → 217].
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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 liabilityIn the event that the system owner fails to fulfill its obligation to perform
maintenance activities or ignores error messages, Sirona Dental Syst ems
GmbH and its authorized dealers cannot assume any liability for any
damage thus incurred.
1.6
Intended use
Intended use
This dental treatment center is intended for the diagnosis, therapy and
dental treatment of humans by properly trained and qualified personnel.
Contraindications for the use of the dental treatment center, if any, are
listed in the individual chapters, e.g. Treatment Instruments.
This device is not intended for operation in areas subject to explosion
hazards.
Intended use also includes compliance with these Operating Instructions
and the relevant maintenance instructions.
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1 General informationSirona Dental Systems GmbH
1.7 Formats and symbols usedOperating Instructions SINIUS / SINIUS CS
1.7
Formats and symbols used
Formats and symbols us ed
The formats and symbols used in this document have the following
meaning:
✔ Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
See "Formats and symbols
used [ → 14]“
● ListDesignates a list.
"Command/menu item"Identifies commands, menu items
Prompts you to do something.
Identifies a reference to another
text passage and specifies its page
number.
or quotations.
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Sirona Dental Systems GmbH2 Safety instructions
Operating Instructions SINIUS / SINIUS CS2.1 Identification of the danger levels
Safety instructions
2
Safety instructions
2.1
Identification of the danger levels
Identification of the da nger 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:
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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Accompanying documents
Electrostatic discharge (ESD)
2.2
2.3
Tip: Information on making work easier.
Information on the unit
Information on the unit
The symbol “Refer to Operating Instructions” is affixed next to the rating
plate.
The Operating Instructions are provided on an electronic data carrier.
This is delivered together with the treatment center.
Connector pins or sockets bearing ESD warning labels must not be
touched or interconnected without ESD protective measures. See also
"Electrostatic discharge" [ → 19] and "Electromagnetic
compatibility" [ → 19].
On-site installation
On-site installation
The on-site installation must have been performed according to our
requirements. The details are described in the document "Installation
Requirements."
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2 Safety instructionsSirona Dental Systems GmbH
2.4 Media qualityOperating Instructions SINIUS / SINIUS CS
2.4
Media quality
Media quality
The air and water supplies must meet the requirements specified in the
installation instructions. Use only drinking water and dry, oil-free and
hygienically clean air for the water and air supplies of the treatment
center.
Disinfection system, optional
To ensure compliance with the medical and national legal requirements
for water from treatment centers, Sirona recommends equipping the
treatment center with a disinfection system. If you decide to operate the
treatment center without a disinfection system, you must make alternative
arrangements to ensure good water quality.
As the owner of the treatment center, you are generally responsible for
the water quality.
For this reason, you should check the water quality at regular intervals,
see "Microbiological inspection of the water" [ → 170]. Please contact your
specialized dealer or your relevant dental association for the respective
national requirements and measures. Where necessary, you must make
alternative arrangements to ensure good water quality if you decide to
operate the treatment center without a disinfection system.
Immunosuppressed patients, with sterile solution
Highly immunosuppressed patients should not come in contact with water
from the treatment center. The use of sterile solutions is recommended.
Authorized technical personnel and
spare parts
2.5
2.6
Connection to the public drinking water system
Free discharge where no disinfection system exists
Connection to the publ ic drinking water s ystem
Provided it is equipped with a disinfection system, the treatment center
provides free discharge in the water supply (isolating distance ≥ 20 mm).
This isolates the public drinking water system from the water supplies
following free discharge. The requirements of EN 1717 are thereby
fulfilled.
The treatment center meets the requirements of the DVGW (German Gas
and Water Association).
It is intrinsically safe in accordance with worksheet W540 and therefore
fulfills the requirements of W270 and KTW (plastics in waterways). The
German Gas and Water Association (DVGW) approval can be viewed on
a label next to the rating plate.
Structural measures if no disinfection system is availabl e
Provided the treatment center is not equipped with a disinfection system,
structural measures may be required beyond the unit to protect the public
drinking water system.
Please always adhere to the national requirements with regard to
connecting treatment centers to the public drinking water system.
Maintenance and repair
Maintenance and repair
As manufacturers of dental medical units and in the interest of the
operational safety of your system, we stress the importance of having
maintenance and repair of this unit performed only by ourselves or by
agencies expressly authorized by us. Furthermore, failed components
must always be replaced with original spare parts.
Certificate, with modification n ote
We suggest that you request a certificate showing the nature and extent
of the work performed from those who carry out such work; it must contain
any changes in rated parameters or working ranges (if applicable), as well
as the date, the name of the company and a signature.
Maintenance intervalsDespite the outstanding quality of your treatment center and regular care
by the practice team, in the interest of operational safety, it is essential to
have preventive maintenance performed at scheduled intervals.
In order to ensure the operational safety and reliability of your treatment
center and to avoid damage due to natural wear, you as the system owner
must have your system checked regularly by an authorized service
engineer from your dental depot. Furthermore, safety checks must be
performed. Please contact your dental depot to obtain a maintenance
offer. For more information, please refer to "Maintenance by the service
engineer" [ → 217].
2.7
2.8
2.9
Trouble-free operation
Trouble-free operation
Use of this unit 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.
Vacuum system
Suction of aluminum or other metal oxides prohibited
Vacuum system
The suction removal of aluminum and other metal oxides from blasting
devices via the amalgam separator and the automatic separator installed
in the treatment center is prohibited! This would result in extreme wear
and clogging of the vacuum and drain lines.
Separate suction
A separate vacuum system must be used in connection with metal oxide
blasting devices. Treatment centers equipped with a central wet suction
system are generally suitable for suction removal of the above material.
However, make sure to observe the instructions provided by the
manufacturer of your vacuum system.
Suction of steel abrasives perm issible
No restrictions apply when using salt blasting devices in connection with
Sirona treatment centers. However, in such cases, make sure that the
system is subsequently flushed with an adequate amount of water.
Patient chair
Patient chair
Please observe the maximum load capacity of 165 kg for the patient
chair.
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The weight distribution complies with ISO 6875. The mechanical stability
test is performed with a multiple safety factor according to IEC 60601-1.
The maximum permissible weight of accessories mounted on the patient
chair is 5 kg.
The patient’s arms and legs must be resting on the upholstery of the
chair.
Under no circumstances may the ventilation slots on the unit be covered,
since otherwise the air circulation will be obstructed. This can cause the
unit to overheat.
Do not spray liquids such as disinfectants into the ventilation slots. This
may lead to malfunctions. Use wipe disinfection only in the vicinity of the
ventilation slots.
Intermittent operation
Intermittent operation
The motors of the treatment center and of the treatment instruments are
designed for intermittent operation corresponding to the dental mode of
treatment.
Drive motors for patient chair and backrest: max. 10% duty cycle, cycle
duration 1200s
Touchscreen
Touchscreen
The monitor of the dentist element is equipped with touch-sensitive
control technology.
The touchscreen must not be operated with pointed objects such as ballpoint pens, pencils, etc. Such objects could damage or scratch its
surface. Always operate the touchscreen by pressing it gently with your
fingertip.
2.13
2.14
Care and cleaning agents
Care and cleaning agents
Unsuitable care and cleaning agents may corrode the surface of the unit
or impair its functioning.
Therefore, use only care and cleaning agents which have been approved
by Sirona. For more information, please refer to "Care and cleaning
agents" [ → 170].
Modifications and extensions of the system
Modifications and exte nsions of the sys tem
Modifications to this system 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 Sirona accessories or third-party accessories expressly approved
by Sirona. The user assumes the risk of using non-approved accessories.
If any devices not approved by Sirona are connected, they must comply
with the applicable standards, e.g.:
● IEC 60950 for information technology equipment (e.g. PC) and
● IEC 60601-1 for medical electrical equipment.
The treatment center monitor must fulfill the requirements of the
IEC 60950 standard.
The loudspeaker port of the monitor may be connected only to a device
that complies with IEC 60950 (e.g. a PC) or
IEC 60601-1. Under no circumstances may it be connected to a stereo
system, or similar, for example.
If a system is created during the installation process, the requirements of
IEC 60601-1, 3rd edition, must be fulfilled. The system author assumes
responsibility for conformity of the system with 93/42/EEC Directive.
2.15
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 as specified in the document “Installation
Requirements”.
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of such devices (e.g.
cellular phones) in practice or hospital environments must be prohibited.
SIVISION digital and USB interface
The presence of electromagnetic interference in the vicinity of the
treatment center may cause image degradation and interruptions in the
data transmission via the USB interface to the PC. In such cases please
repeat the image recording or other operations.
In the event of heavy interference, it may be necessary to restart the PC.
It is therefore not recommended to use the PC for controlling other
devices that provide essential performance components.
Wireless foot control
The wireless foot control may interfere with other devices in the same
frequency band (2.4 GHz) or receive interfering signals from them. The
safe condition of the treatment center is guaranteed even if the wireless
transmission is compromised.
Electrostatic discharge from people can damage electronic components
when the components are touched. Damaged components usually have
to be replaced. Repairs must be performed by qualified personnel.
● discharging the electrostatic charges from your own body through
contact with
–the metallic device casing
–a larger metallic object
–another grounded protective ground wire
● wearing an antistatic band that creates a connection between the
body and a protective ground wire.
Areas at risk are indicated on the unit with the ESD warning label:
We recommend that all persons working with this system are made aware
of the significance of the ESD warning label. A training course should also
be held to inform users about the physics of electrostatic charges.
Physics of electrostatic charges
An electrostatic discharge requires prior electrostatic charging.
There is a danger of electrostatic charges building up whenever two
bodies rub against each other, e.g. when:
● walking (soles of shoes against the floor) or
● driving (tires against the road surface).
The amount of charge depends on several factors: The charge is:
● higher at low air humidity than at high air humidity, and
● higher with synthetic materials than with natural materials (clothing,
floor coverings).
The following rule of thumb can be applied to assess the transient
voltages resulting from an electrostatic discharge.
An electrostatic discharge is:
● perceptible at 3,000 V or higher
● audible at 5,000 V or higher (cracking, crackling)
● visible at 10,000 V or higher (spark-over)
The transient currents resulting from these discharges have a magnitude
of 10 amps. They are not hazardous for humans because they last for
only several nanoseconds.
Tip: 1 nanosecond = 1/1,000,000,000 second = 1 billionth of a second
Voltage differentials exceeding 30,000 volts per centimeter may lead to a
charge transfer (electrostatic discharge, lightning, spark-over).
Integrated circuits (logical circuits and microprocessors) are used in order
to implement a wide variety of functions in a device. The circuits must be
miniaturized to a very high degree in order to include as many functions
as possible on these chips. This leads to structure thicknesses as low as
a few ten thousandths of a millimeter. Integrated circuits that are
connected to wires leading externally are therefore particularly at risk
from electrostatic discharge.
Even voltages that are imperceptible to the user can cause breakdown of
the structures, thus leading to a discharge current that melts the chip in
the affected areas. Damage to individual integrated circuits may cause
malfunction or failure of the unit.
2.17
Dismantling/Installation
Follow the installation instruc tions
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.
The SINIUS / SINIUS CS® treatment center complies with the following
standards, among others:
● IEC 60601-1 (electrical and mechanical safety plus software
reliability)
● IEC 60601-1-2 (electromagnetic compatibility)
● IEC 60601-1-6 (serviceability)
● ISO 6875 (Patient chair)
● ISO 7494-1 (Dental treatment devices)
● ISO 7494-2 (dental treatment units, water and air supply)
● ISO 9680 (Operating light)
● ISO 11143 (amalgam separator), see also below
(if amalgam separator option is present)
● EN 1717 (connection to the drinking water system), see also below and
the chapter titled "Connection to the drinking water system“ [ → 16]
Original language: German
CE mark of the BHE
This product bears the CE mark in accordance with the provisions of
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
Ü mark of the amalgam separator
The amalgam separator achieves a separation efficiency of > 95%. The
unit thus fulfills the requirements of ISO 11143.
Separating procedure type 1: Centrifugal system
The amalgam separator is approved by the German Institute for
Structural Engineering (DIBT) and by the French International
Organization for Standardization (AFNOR).
German Gas and Water Asso ciation (DVGW) certified connection for G ermany
When equipped with a disinfection system, the treatment center complies
with the technical rules and requirements on safety and hygiene for
connection to the public drinking water supply. The unit is certified
according to the requirements of the DVGW (Deutscher Verein für Gas
und Wasser = German Gas and Water Association). It is intrinsically safe
in accordance with worksheet W540. The unit also meets, therefore, the
requirements of standard EN 1717; see also the chapter entitled
"Connection to the public drinking water system" [ → 16].
BELG AQUA for Belgium
This unit meets the requirements of BELGAQUA and may therefore be
connected to the public drinking water supply in Belgium.
headrest [ → 30]
CFoot control [ → 31] (with cable or wireless link)
DDentist element SINIUS on the travel track [ → 32]
EAssistant element [ → 39]
FWater unit [ → 41]
GExternal device connection [ → 43] and power switch
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Sirona Dental Systems GmbH3 Unit description
Operating Instructions SINIUS / SINIUS CS3.3 System overview
headrest [ → 30]
CFoot control [ → 31] (with cable or wireless link)
DSINIUS CS dentist element with swivel arms on support arm [ → 32]
EAssistant element [ → 39]
FWater unit [ → 41]
GExternal device connection [ → 43] and power switch
The patient chair features a variety of motor adjustment options to
optimally adapt the patient's position to the given treatment.
AMotor-driven headrest (shown here) or articulating headrest
BBackrest
CSeat
DArmrest
EFootrest
FChair base
GFlange on the SINIUS dentist element travel track
H4-way foot switch
IFoot control cable port
JRotary joint for assistant element
The headrest allows for the following adjustment options:
● Motor-driven extension/retraction to adapt to the patient's stature
● Motor-driven tilting for maxillary/mandibular treatment
● Manual tilting via quick mechanical adjustment
● Shifting/rotation of the head support via the magnetic holder
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ARemovable head pad with magnetic holder
BQuick mechanical adjustment of headrest tilt
CUpper 4-way switch for headrest functions
DLower 4-way switch for chair functions
For details, see "Adjusting the motor-driven headrest" [ → 64].
The double-jointed headrest is equipped with two rotary joints. They allow
the adjustment of head inclination for maxillary/mandibular treatment to a
great extent. The headrest extension can be pulled in or out to suit the
height of the patient.
ARemovable head pad with Velcro fasteners
BRotary joints
CUnlock button (one-sided)
DSupport bar for adjustment to patient height
For details, see "Adjusting the double-jointed headrest" [ → 66].
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