Sirona Heliodent User Manual
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SX-ray
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7 mA 60 kV DC
WARNING:
This X-ray unit may be dangerous to patient and operator unless
safe exposure factors and operating instructions areobserved.
Unauthorized use is prohibited.
HELIODENT DS
General information Sirona Dental Systems GmbH
Operating Instructions HELIODENT DS
General information
Dear customer, Thank you for purchasing your HELIODENT DS.
Both intraoral and mandibular joint radiography can be
performed with this unit.
The technical documentation included in delivery, i.e.
operating instructions, installation instructions,
Installation report / Warranty passport, customer installation description and X-ray system file (only in the
FRG), are also an integral part of this product.
Keep these documents nearby for quick and easy reference at all times (in the FR of Germany: in your X-ray
system file).
In order to protect your warranty rights, please complete
the enclosed Installation report / Warranty passport,
together with the service technician, immediately after
installation of your system.
Read the Operating Instructions to familiarize yourself
with the product before taking X-rays on the patient.
Always be sure to observe the currently valid Radiation
Protection Guidelines and the Safety Notes in these
Operatingf Instructions.
The ordinance governing the use of radiation emitting
equipment in the Federal Republic of Germany requires
the operator to perform regular constancy tests to
ensure the safety of operating personnel and patients.
Your HELIODENT team
Maintenance To ensure the safety and health of patients, operators
and third parties, inspections and maintenance calls
must be carried out at the specified intervals in order to
guarantee the operational safety and functional reliability
of your product (IEC 601-1 / DIN EN 60601-1 etc.).
It is the responsibility of the operator to ensure that the
required inspections and maintenance work are carried
out.
In the event that the operator fails to fulfill the obligation
to carry out inspections and maintenance or ignores
error messages, Sirona Dental Systems GmbH and/or
its authorized dealers can not assume liability for any
damage attributable to this.
This product bears the CE label in accordance with the
provisions of the
Council Directive 93/42/EWG of June 14,1993 concern-
0123
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ing medical devices.
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Sirona Dental Systems GmbH Contents
Operating Instructions HELIODENT DS
Contents
1 Warning and safety information ................................................................................... 4
2 Technical Description .................................................................................................... 6
3 Controls and display elements ................................................................................... 10
4 Accessories .................................................................................................................. 11
5 Preparing an exposure ................................................................................................ 12
5.1 Switching the unit ON ........................................................................................................................ 12
5.2 Selecting the radiographic technique................................................................................................. 13
5.3 Basic setting at factory....................................................................................................................... 14
5.4 Adjusting the basic setting................................................................................................................. 15
5.5 Setting the exposure data.................................................................................................................. 16
6 Positioning the patient/x-ray tube unit....................................................................... 17
7 Bite-wing exposure ...................................................................................................... 18
8 Exposure of the mandibular joint ............................................................................... 18
9 Releasing an exposure ................................................................................................ 19
10 Mobile stand / overhead model / Centro Column / Split Concept (optional) .......... 20
11 Exposure times............................................................................................................. 22
11.1 Possible exposure times.................................................................................................................... 22
11.2 Exposure times with 8" source-skin distance tube - Class E film ......................................................22
11.3 Exposure times with 12" source-skin distance tube - Class E film
(Round or square cone)..................................................................................................................... 22
11.4 Exposure times for Sirona Full Size / Universal X-ray sensors with 8"FHA tube ...............................23
11.5 Exposure times for Sirona Full Size / Universal X-ray sensors with 12"FHA tube
(Round or square cone)..................................................................................................................... 23
11.6 Exposure times using tube with 8" SSD - General X-ray sensors .....................................................24
11.7 Exposure times using tube with 12" SSD - General X-ray sensors (Round or square cone) ............ 24
12 Care of surfaces ........................................................................................................... 25
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13 List of error codes........................................................................................................ 26
14 Inspection and maintenance ....................................................................................... 27
14.1 Annual inspection performed by the operator or other authorized personnel.................................... 27
14.2 Maintenance performed by the service technician ............................................................................ 27
14.3 Checking image quality...................................................................................................................... 27
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1 Warning and safety information Sirona Dental Systems GmbH
Operating Instructions HELIODENT DS
1 Warning and safety information
Marking of warning and
safety information
To prevent personal injury and damage to property,
please observe the warning and safety information provided in these operating instructions. They are specially
marked with a warning symbol and ATTENTION.
Symbols used Observe accompanying documents (on name
plate)
Proper use This unit is designed for the preparation of intraoral
X-rays and X-rays of the mandibular joint.
The unit must not be used in explosion hazard areas.
General safety information Patient X-ray exposures may be performed only when
the unit is functioning flawlessly.
The patient must not be left unattended at the unit.
Modifications to the system Modifications to this system which could impair the
safety of operators, patients or third 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 is responsible for dangers resulting from the
use of non-approved accessories.
Disturbance of electronic equipment worn by the
patient.
To prevent the malfunction of electronic devices and
loss of stored data in connection with radio controlled
clocks, telephone cards, etc. all such items must be
removed from the patient prior to the X-ray exposure.
Radiation protection The applicable radiation protection regulations must be
observed. The prescribed radiation protection accessories must be used.
If the release button is equipped with a cable, the operator must leave the vicintiy of the X-ray tube unit before
triggering an exposure.
No one except the patient may remain in the exposure
room. In exceptional cases a third party who is not a
member of the practice staff may assist the patient.
Visual contact with the patient and the unit must be
maintained during every X-ray exposure.
In case of malfunction, interrupt the exposure immediately by letting go of the release button.
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Sirona Dental Systems GmbH 1 Warning and safety information
Operating Instructions HELIODENT DS
Electromagnetic compatibility (EMC) The HELIODENT DS complies with the requirements of
IEC 60601-1-2:2001.
Medical electrical devices are subject to special precautionary measures regarding EMC. They must be
installed and operated as specified in the document
"Installation Requirements".
Portable and mobile HF communication devices can
influence medical electrical equipment. The use of
mobile telephones in the practice or hospital area therefore must be prohibited.
Disposal It applies generally that the national regulations have to
be complied with when disposing of this product. Please
observe the regulations applying in your country.
Within the European Economic Community the directive
2002/96/EEC (WEEE) for electrical and electronic
devices requires environmentally compatible recycling /
disposal.
Your product is marked with the adjacent symbol. With
the goal of environmentally compatible recycling / disposal, your product must not be disposed of with the
domestic refuse.
The black bar under the "refuse bin" symbol means that
it has been put onto the market after 13.08.2005. (See
EN 50419:2005)
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Please note that this product is subject to the directive
2002/96/EEC (WEEE) and laws applicable in your country and must be sent for environmentally compatible
recycling / disposal.
The X-ray tube assembly of this product contains a
tube with a potential implosion hazard, a lead lining and
mineral oil.
Please contact your dealer if your product should be
finally disposed of.
Dismantling and reassembly When dismantling and reassembling the unit, always
proceed as outlined in the instructions for reassembly.
This is necessary to ensure the unit’s proper functioning
and stability.
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2 Technical Description Sirona Dental Systems GmbH
Operating Instructions HELIODENT DS
2 Technical Description
Technical Data
Nominal voltage:
Permissible line voltage fluctuations:
Nominal current: at 230V: 4.6A
Rated line frequency: 50Hz / 60Hz
Line impedance: at 230V: 0.8 Ohm
House wiring fuse: 16A
Power requirement: < 1.5kW
Tube voltage: 60kV
Tube current: 7mA
High-voltage curve: Multipulse X-ray tube
Radiation times: 0.01 – 3.s
Mark-to-space ratio: 1:30 (radiation-time-dependent overheating protection)
Total filtration in X-ray tube unit:
Focal spot size acc. to IEC 336:
Petrick P470/6.30/12G 0.4mm
Focal spot mark:
200 – 230V or 127V
+ 6% –10% (200 – 230V), ± 10% (127V)
at 127V: 11A
at 127V: 0.3 Ohm
> 2mm Al / 70 kV IEC 60 522
SSD 8” (203mm) or 12” (305mm) = source-skin distance
Diameter of radiation field at tube end: < 60 mm
Type of protection against electric shock: Protection class I
Degree of protection against electric shock: Type B
Degree of protection against penetration of water: Conventional unit
(w/o protection against penetration of water)
Year of manufacture: (on the rating plate)
Operating mode: Continuous operation
Continuous power rating: 30W max
Rating (60kV, 7mA) 420W max
Anode material: Tungsten
Exposure data to determine leakage radiation: 0.25mA/60kV
Leakage radiation
Filament
Nominal line voltage: 6,6V
Nominal current: 1,6A
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< 0.25 mGy/h
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Sirona Dental Systems GmbH 2 Technical Description
Operating Instructions HELIODENT DS
Technical Data
Nominal frequency: DC
Duty cycle: 1:30
Operating conditions (compliant with IEC 601-1) Ambient temperature: 10°C – 40°C (50°F – 104°F)
Relative humidity: 30% – 75%
Transport and storage conditions (compliant with IEC 601-1) Temperature: -40° C – +70° C (-40°F – 158°F)
Relative humidity: 10% – 95%
HELIODENT DS has been inspected by the VDE Testing and Certification Institute for compliance with:
• IEC 60 601-1
• IEC 60 601-2-28 / 1993
• IEC 60 601-1-3 / 1994
• IEC 60 601 -2-7 / 1998
HELIODENT DS has been found to comply with these regulations.
The HELIODENT DS X-ray unit complies with AS / NZS 3200.1.0
Reg. No.: China
Reg. No.: China
SFDA (I) 20053301170
Original language of Operating Instructions: German
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2 Technical Description Sirona Dental Systems GmbH
Operating Instructions HELIODENT DS
Illumination
Central ray
Sizes and Weight
FHA
Anode angle 24° ± 1°
132
Focal spot marc
102
∅64.5
∅161 169.3
No true scale.
Approx. length values.
Weight: approx. 3.4kg
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Sirona Dental Systems GmbH 2 Technical Description
Operating Instructions HELIODENT DS
Cool-down curve for X-ray tube housing
Joule x10
120
100
80
60
40
20
3
0
20 40 60 80 100 120 140 160 180 200 220 t (min)
Cool-down curve for X-ray tube
Joule
5000
4000
3000
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2000
1000
0
1234t(min)
Warm-up curve for X-ray tube housing
Joule x10
120
100
80
60
40
20
0
3
20 40 60 80 100 120 140 160 180 200 220 t (min)
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