Sirona Heliodent User Manual

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X-ray 0.06 S

7 mA 60 kV DC	Digital	D

HELIODENT	DS

WARNING:

This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited.

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 instal-
	lation 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 refer-
	ence 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
						ing medical devices.
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Sirona Dental Systems GmbH	Contents
Operating Instructions HELIODENT DS

Contents

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Warning and safety information ...................................................................................		4
Technical Description ....................................................................................................		6
Controls and display elements ...................................................................................		10
Accessories ..................................................................................................................		11
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
Positioning the patient/x-ray tube unit.......................................................................		17
Bite-wing exposure ......................................................................................................		18
Exposure of the mandibular joint ...............................................................................		18
Releasing an exposure ................................................................................................		19
Mobile stand / overhead model / Centro Column / Split Concept (optional) ..........		20
Exposure times.............................................................................................................		22
11.1	Possible exposure times....................................................................................................................	22
11.2	Exposure times with 8" source-skin distance tube - Class E film ......................................................	22

11.3Exposure 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

11.5Exposure 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
Care of surfaces ...........................................................................................................		25
List of error codes........................................................................................................		26
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

Disturbance of electronic equipment worn by the patient.

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.

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 accesso-
	ries must be used.
	If the release button is equipped with a cable, the opera-
	tor 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 immedia-
	tely 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 precau-
		tionary 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 there-
		fore 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 / dis-
		posal, 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)
		Please note that this product is subject to the directive
		2002/96/EEC (WEEE) and laws applicable in your coun-
		try 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:

Rated line frequency:

Line impedance:

House wiring fuse:

Power requirement:

Tube voltage:

Tube current:

High-voltage curve:

Radiation times:

Mark-to-space ratio:

Total filtration in X-ray tube unit:

Focal spot size acc. to IEC 336:

Petrick P470/6.30/12G

Focal spot mark:

Diameter of radiation field at tube end: Type of protection against electric shock: Degree of protection against electric shock:

Degree of protection against penetration of water:

Year of manufacture:

Operating mode:

Continuous power rating:

Rating (60kV, 7mA)

Anode material:

Exposure data to determine leakage radiation: Leakage radiation

Filament

Nominal line voltage:

Nominal current:

6

200 – 230V or 127V

+ 6% –10% (200 – 230V), ± 10% (127V)

at 230V: 4.6A at 127V: 11A

50Hz / 60Hz

at 230V: 0.8 Ohm

at 127V: 0.3 Ohm

16A

< 1.5kW

60kV

7mA

Multipulse X-ray tube

0.01 – 3.s

1:30 (radiation-time-dependent overheating protection)

> 2mm Al / 70 kV IEC 60 522

0.4mm

SSD 8” (203mm) or 12” (305mm) = source-skin distance

< 60 mm

Protection class I

Type B

Conventional unit

(w/o protection against penetration of water)

(on the rating plate)

Continuous operation

30W max

420W max

Tungsten

0.25mA/60kV

< 0.25 mGy/h

6,6V

1,6A

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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

Focal spot marc

FHA

Central ray

Anode angle 24° ± 1°

Sizes and Weight

132	102
		64.5
	161	169.3
		No true scale.
		Approx. length values.
		Weight: approx. 3.4kg

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Sirona Dental Systems GmbH

Operating Instructions HELIODENT DS

Cool-down curve for X-ray tube housing

Joule x103

120

100

80

60

40

20

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

2000

1000

0

1

2

3

4

t(min)

Warm-up curve for X-ray tube housing

Joule x103

120

100

80

60

40

20

0

20 40 60 80 100 120 140 160 180 200 220 t (min)

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2 Technical Description

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