Sirona Heliodent Plus User Manual

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		PLUS
0.08S		HELIODENT
7mA DC
70kV	60kV
	0.08S		PLUS
	7mA DC		HELIODENT
	70kV	60kV
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Sirona Dental Systems GmbH	Table of contents
Operating Instructions HELIODENTPLUS

Table of contents

1	General data............................................................................................................		5
	1.1	Preface.........................................................................................................	5
	1.2	General information about this operating manual ........................................	5
	1.3	Contact information......................................................................................	6
	1.4	Warranty and liability....................................................................................	6
	1.5	Intended use.................................................................................................	7
		1.5.1 Indication and contraindication........................................................	7
	1.6	Structure of the document............................................................................	8
		1.6.1 Identification of the danger levels....................................................	8
		1.6.2 Formats and symbols used.............................................................	8
2	Safety information....................................................................................................		9
	2.1	Information on the unit..................................................................................	9
	2.2	Risk of crushing............................................................................................	9
	2.3	Maintenance.................................................................................................	10
	2.4	Modifications to the product .........................................................................	10
	2.5	Condensation...............................................................................................	10
	2.6	Qualifications of operating personnel...........................................................	10
	2.7	Radiation protection .....................................................................................	11
	2.8	Hygiene........................................................................................................	11
	2.9	Trouble-free operation..................................................................................	11
	2.10	Interference with electronic devices.............................................................	11
	2.11	Risks of electromagnetic fields.....................................................................	12
	2.12	Electromagnetic compatibility.......................................................................	12
3	Technical description...............................................................................................		13
	3.1	Technical data..............................................................................................	13
	3.2	Diagrams......................................................................................................	15
	3.3	Certification, registration and standards.......................................................	16
4	Controls and functional elements............................................................................		17
	4.1	Operating and Display Elements..................................................................	17
	4.2	Meaning of the icons....................................................................................	18
	4.3	Display structure...........................................................................................	19
	4.4	Version Ceiling model/Ceiling combination..................................................	19
	4.5	Mobile stand variant.....................................................................................	20

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Table of contents	Sirona Dental Systems GmbH
	Operating Instructions HELIODENTPLUS

5

6

7

8

9

10

4.6	Version Unit model........................................................................................		22
4.7	Accessories...................................................................................................		23
4.8	Exposure times .............................................................................................		24
	4.8.1 Possible exposure times in seconds................................................		24
	4.8.2 Pre-programmed exposure times for films of sensitivity class E and		24
		with a 200 mm (8") FHA cone
	4.8.3 Pre-programmed exposure times for films of sensitivity class E and		25
		with a 300 mm (12") FHA cone
	4.8.4 Pre-programmed exposure times for XIOS XG sensors with 200		26
		mm (8") FHA cone
	4.8.5 Pre-programmed exposure times for XIOS XG sensors with 300		27
		mm (12") FHA cone (round or square cone)
Operation..................................................................................................................			28
5.1	Preparing the exposure.................................................................................		28
	5.1.1 Switch the unit on.............................................................................		28
	5.1.2 Selecting the tooth icon....................................................................		28
	5.1.3 Selecting the patient symbol............................................................		29
	5.1.4 Checking the kV value: ....................................................................		29
	5.1.5	Plus/Minus keys...............................................................................	29
	5.1.6 Checking the imaging technology....................................................		29
5.2	Positioning the patient/X-ray tube assembly.................................................		30
5.3	Releasing the exposure ................................................................................		31
5.4	Adapting basic settings.................................................................................		33
Maintenance.............................................................................................................			35
6.1	Cleaning and care.........................................................................................		35
	6.1.1	Cleaning...........................................................................................	35
	6.1.2	Disinfecting.......................................................................................	35
	6.1.3	Maintenance of accessories.............................................................	36
6.2	Inspection and maintenance.........................................................................		37
Error messages........................................................................................................			38
7.1	List of error messages...................................................................................		38
Dismantling and disposal .........................................................................................			40
8.1	Dismantling and reinstallation.......................................................................		40
8.2	Disposal ........................................................................................................		40
	8.2.1 Disposal of the X-ray tube assembly................................................		41
Dose area product (DFP).........................................................................................			42
Brief Operating Instructions......................................................................................			45

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Sirona Dental Systems GmbH	1 General data
Operating Instructions HELIODENTPLUS	1.1 Preface

1 General data

1.1Preface

Dear Customer,

Thank you for purchasing the HELIODENTPLUS X-ray system. This system can be used to take intraoral X-rays.

Please familiarize yourself with the unit by reading through these Operating Instructions before taking any X-rays of patients.

Please comply with the applicable radiation protection regulations and warnings at all times.

SIRONA requires regular constancy tests to ensure image quality.

Your HELIODENTPLUS team

1.2General 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.
Keep documents safe	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.sirona.com/manuals. From here, you can download these
	Operating Instructions along with other 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 reach an impasse despite having thoroughly studied the operating
	instructions, please contact your dental depot.

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1 General data	Sirona Dental Systems GmbH
1.3 Contact information	Operating Instructions HELIODENTPLUS

1.3	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" andthen click the"CONTACT
	FORM FOR TECHNICAL QUESTIONS" button.
Manufacturer's address	Sirona Dental Systems GmbH
	Fabrikstrasse 31
	64625 Bensheim
	Germany
	Phone: [phone]
	Fax: [phone]
	e-mail: [e-mail]
	www.sirona.com

1.4	Warranty and liability
Maintenance	In the interest of the safety and health of patients, users and other
	persons, inspection and preventive maintenance must be performed at
	scheduled intervals to ensure the operational reliability and functional
	safety of your product (IEC 60601-1 / DIN EN 60601-1 etc.).
	The system owner must ensure that all inspections and maintenance
	events take place.
	As manufacturers of medical electrical equipment, we can assume
	responsibility for the safety properties of the system only if maintenance
	and repair work on the system is performed by ourselves or by agencies
	expressly authorizedby us,andif components affectingsafeoperationof
	the system are replaced by original spare parts in case of failure.
Exclusion of liability	If the system owner fails to fulfill the obligation to have inspections and
	maintenance work performed or ignores error messages, Sirona Dental
	SystemsGmbHanditsauthorizeddealerscannotassumeanyliabilityfor
	resulting damage.
Certificate of work	We suggest that you request a certificate, showing the nature and extent
	of the work performed, from those who carry out such work, and specify
	that the certificate show any changes in rated parameters or working
	ranges, as well as the date, the name of the firm and a signature.

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Sirona Dental Systems GmbH	1	General data
Operating Instructions HELIODENTPLUS	1.5	Intended use

1.5Intended use

This system must not be used in areas subject to explosion hazards.

The HELIODENTPLUS is an extraoral X-ray system. It is intended for use in dental radiographic examination and diagnosis of diseases and disorders of the teeth, the jaw and oral structures.

With room temperatures > 35°C (> 95°F) Sirona recommends the use of an air conditioning system.

Recommended operating temperature: 18 °C - 35 °C (64 °F - 95 °F)

United States only

CAUTION Federal law (USA) restricts sale of this device to or on the order of a physician, dentist, or licensed practitioner.

1.5.1Indication and contraindication

Indications in the areas:

●Conservative dentistry

●Caries diagnosis, especially of proximal lesions

●Endodontics

●Periodontology

●Prosthodontics

●Functional diagnosis and therapy of craniomandibular dysfunctions

●Surgical dentistry

●Implantology

●Oral and maxillofacial surgery

●Orthodontics

Contraindications:

●Display of cartilage structures

●Display of soft tissue

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1 General data	Sirona Dental Systems GmbH
1.6 Structure of the document	Operating Instructions HELIODENTPLUS

1.6Structure of the document

1.6.1Identification of the danger levels

To prevent personal injury and material damage, please observe the warning and safety information provided in the present operating instructions. 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.

Tip: Information on making work easier.

1.6.2Formats and symbols used

The formats and symbols used in this document have the following meaning:

Prerequisite

Requests you to do something.

1.First action step

2.Second action step

or

Alternative action

	Result
	Individual action step
See "Formats and symbols		Identifies a reference to another text
used [→8]"		passage and specifies its page
		number.
●	List	Designates a list.
"Command / menu item"		Indicates commands, menu items or
		quotations.

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Sirona Dental Systems GmbH	2 Safety information
Operating Instructions HELIODENTPLUS	2.1 Information on the unit

2 Safety information

2.1Information on the unit

Accompanying documents

This symbol is affixed next to the unit rating plate.

Meaning: When operating the unit, observe the operating instructions.

This symbol is affixed on the unit rating plate.

Meaning: The accompanying documents are available on the homepage of Sirona.

2.2Risk of crushing

CAUTION

Gaps appear between the internal hinges when moving the angular support arm.

Fingers may be crushed in these gaps.

Ensure that you never place your fingers in the gaps between the hinges, neither during operation nor for cleaning purposes.

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2 Safety information	Sirona Dental Systems GmbH
2.3 Maintenance	Operating Instructions HELIODENTPLUS

2.3 Maintenance

In the interest of the safety and health of patients, users and other persons, inspection and preventive maintenance must be performed at scheduled intervals to ensure the operational reliability and functional safety of your product (IEC 60601-1 / DIN EN 60601-1 etc.).

The system owner must ensure that all inspections and maintenance events take place.

If the system owner fails to fulfill the obligation to have inspections and maintenance work performed or ignores error messages, Sirona Dental SystemsGmbHanditsauthorizeddealerscannotassumeanyliabilityfor resulting damage.

As manufacturers of medical electrical equipment we can assume responsibility for the safety-related features of the equipment only if maintenance and repair are carried out only by ourselves or agencies expressly authorizedby us,andif components affectingsafeoperationof the system are replaced with original spare parts upon failure.

We suggest that you request a certificate showing the nature and extent oftheworkperformedfromthosewhocarryoutsuchwork;itmustcontain anychangesinratedparametersorworkingranges(ifapplicable),aswell as the date, the name of the company and a signature.

2.4	Modifications to the product
	Modifications to this product which may affect the safety of the operator,
	patients or third parties are prohibited by law!
2.5	Condensation
	Extreme fluctuations of temperature may cause condensation inside the
	unit. Do not switch the unit on before it has reached normal room
	temperature. See the chapter on “Technical data”.
2.6	Qualifications of operating personnel
	The system may only be operated by skilled or properly trained
	personnel.

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Sirona Dental Systems GmbH	2 Safety information
Operating Instructions HELIODENTPLUS	2.7 Radiation protection

2.7Radiation protection

The valid radiation protection regulations and measures must be observed. The statutory radiation protection equipment must be used. In ordertoreduceradiationexposure,Sironarecommendsusingbismuthor lead shields or aprons, especially for pediatric patients.

Duringanexposure,theoperatorshouldmoveasfarawayfromtheX-ray tube assembly as the coiled cable of the manual release permits.

With the exception of the patient, no other persons without radiation protection are allowed to stay in the room during an exposure. In exceptional cases, a third person may provide assistance, but not the practice staff.

If the patient is within reach of the unit including its operating elements, theymustbesupervised.Visualcontactwiththepatientandtheunitmust be maintained throughout the entire exposure.

In case of malfunctions, cancel the exposure immediately by letting go of the exposure release button.

2.8Hygiene

Suitable hygienic measures must be taken to prevent cross contamination among patients, operators and other persons.

Before positioning the patient in the unit, you must ensure that

●all auxiliary X-ray equipment is used and prepared (sterilized and/or disinfected) in accordance with manufacturer specifications (e.g. hygienic protective sleeves).

Compliance with the hygienic measures prevents the transmission of infections that can trigger severe illnesses.

2.9Trouble-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.

The device may only be operated with a complete cover and protective hood.

2.10Interference with electronic devices

To prevent the malfunctioning of electronic devices and data storage devices, e.g. radio-controlled watches, telephone cards, etc., these objects must be removed prior to X-raying.

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2 Safety information	Sirona Dental Systems GmbH
2.11 Risks of electromagnetic fields	Operating Instructions HELIODENTPLUS

2.11Risks of electromagnetic fields

The function of implanted systems (cardiac pacemakers or cochlear implants, for example) can be affected by electromagnetic fields. Before commencingtreatment,askifthepatienthasacardiacpacemakerorany other implanted system.

Any prevailing risks are listed in the documentation provided by the equipment manufacturer.

2.12Electromagnetic compatibility

The acquisition unit complies with the requirements of the standard IEC 60601-1-2.

Medical electrical devices are subject to special precautionary measures with regard to EMC. It must be installed and operated as specified in the document “Installation Requirements”.

Portable and mobile RF communications equipment may interfere with medical electrical equipment.

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Sirona Dental Systems GmbH	3 Technical description
Operating Instructions HELIODENTPLUS	3.1 Technical data

3 Technical description

3.1 Technical data

Nominal voltage:	120V, 200V– 240V
Permissible fluctuation:	± 10%
Rated current:	At 120 V: 10A
	At 200 – 240 V: 6 – 5 A
Nominal frequency:	50 Hz / 60 Hz
Internal line impedance:	At 120 V 0.3 ohms
	At 200 – 240 V 0.8 Ohm
Main building fuse:	16 A slow blow
Power input during radiation:	1.2 kW
Power input in standby	< 20 W
mode:
Tube voltage:	60 kV / 70 kV switchable
	(max. tolerance ± 5 kV)
Tube current:	7 mA (max. tolerance ± 1.4 mA)
High-voltage waveform:	DC high frequency
	residual ripple value ≤ 4 kV
High voltage generation	50 kHz - 70 kHz
frequency:
Radiation time:	0.01 – 3.2 s
	(max. tolerance ± 10% +1 ms)
Pulse/pause ratio:	automatic monitoring from 1:1 to 1:60
Total filtration of X-ray tube	> 1.5 AI / 70 IEC 60522
assembly:
Radiation field:	Ø < 60 mm
Dose rate:	8.5 mGy/s ±40% at 60 kV
	11 mGy/s ±40% at 70 kV
Measuring instruments:	PTW Nomex with an ionization space of
	1 cm3 or Unfors mult-o-meter
Measuring conditions:	200 mm focus-meter space
	230 V nominal voltage
Focal spot size as specified	0.4
in IEC 60336:
Focal spot marking O:
	O

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3 Technical description	Sirona Dental Systems GmbH
3.1 Technical data	Operating Instructions HELIODENTPLUS

Source-skin distance:

Class I device

Degree of protection against electric shock:

Degree of protection against ingress of water:

Year of manufacture:

Operating mode:

X-ray tubes:

Nominal continuous power rating of the X-ray tube:

Power rating of X-ray tube (70kW/7mA):

Anode material: Anode angle:

Exposure parameters for determining leakage radiation:

Leakage radiation at 1 m distance:

FHA 200 mm (8") - standard or 300 mm (12")

Type B device

Ordinary equipment (without protection against ingress of water)

(on the rating plate) Continuous operation

Petrick P470/8.35/12G

26 W

490 W

Tungsten 12°

0.12 mA / 70 kV

< 0.25 mGy/h

Transport and operating conditions:

Transport and storage	-40°C – +70°C (-40°F – 158°F)
temperature:
Air humidity:	10% – 95%
Operating conditions as	Ambient temperature +10 °C – +40 °C
specified in IEC 60601-1:	(50 °F – 104 °F)
	Relative humidity: 30% – 75%
Operating altitude:	≤ 3000 m

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Sirona Dental Systems GmbH	3 Technical description
Operating Instructions HELIODENTPLUS	3.2 Diagrams

3.2Diagrams

Cooling curve of tube housing

Joule x103
90
80
70
60
50
40
30
20
10
0	20	30	40	50	60	70	80	90 100 110 120 130 140 150 160 170	t (min)
10

Cooling curve of X-ray tube

Joule
5000
4000
3000
2000
1000
0	2	3	4	t (min)
1

Heating curve of 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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