Sirona XIOS Betriebsanleitung

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61 77 476 D 3495

2D 3495.201.01.02.02 08.2007

1Sirona Dental Systems GmbH

Operating Instructions and Installation XIOS USB

61 77 476 D 3495

D 3495.201.01.02.02 08.2007 3

Sirona Dental Systems GmbH 1

Operating Instructions and Installation XIOS USB Contents

Contents

1Dear Customer,........................................................... 7

1.1 Contents of this document ................................ 7

1.2 General conventions ........................................ 7

1.3 Structure of the documents .............................. 7

1.4 Other valid documents ..................................... 8

2Warning and safety information................................ 9

2.1 ESD protective measures ................................. 11

2.2 About the physics of electrostatic charges ....... 11

3Technical description................................................. 13

3.1 General data ..................................................... 13

3.2 Sensors ............................................................ 13

3.3 USB module ..................................................... 14

3.4 USB cable (supplied by Sirona) ....................... 14

3.5 Ambient conditions ........................................... 14

3.6 Minimum requirements for PC systems ............ 15

3.7 Requirements for intraoral X-ray tube

assemblies ....................................................... 15

3.8 Requirements for the USB hub (optional) ........ 16

4Operating and display elements ............................... 17

4.1 System design .................................................. 17

4.2 USB module ..................................................... 18

4.3 LED displays .................................................... 18

5Installation................................................................... 19

5.1 Prior to installation ............................................ 19

5.2 Installation of the additional protective

ground wire ....................................................... 20

5.3 Installing USB modules .................................... 21

5.3.1 Hardware requirements..................................... 21

5.3.2 Installation instructions ...................................... 21

5.3.3 Installation of a USB module on a PC ............... 21

5.3.4 Installation of additional USB modules on a PC 22

5.4 Installing a sensor ............................................ 23

5.4.1 Installation of hardware ..................................... 23

5.4.2 Software installation .......................................... 23

5.5 Following installation ........................................ 24

61 77 476 D 3495

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1Sirona Dental Systems GmbH

Contents Operating Instructions and Installation XIOS USB

6Accessories and spare parts .................................... 25

6.1 Accessories ...................................................... 25

7Image acquisition ....................................................... 27

7.1 Preparation ....................................................... 27

7.2 Readying the unit for a scan ............................. 27

7.3 Positioning the sensor ...................................... 28

7.4 Releasing the exposure .................................... 28

8Use of the X-ray sensor ............................................. 29

8.1 Preparation ....................................................... 29

8.2 Hygienic protection ........................................... 30

8.2.1 Sliding the hygienic protective sleeve over

the sensor.......................................................... 30

8.2.2 Removing the hygienic protective sleeve from

the sensor.......................................................... 31

8.3 Parallel technique with radiation limiter! ........... 33

8.3.1 Anterior tooth exposure ..................................... 33

8.3.2 Posterior tooth exposures ................................. 34

8.3.3 Bite wing exposures .......................................... 35

8.3.4 Endodontics....................................................... 36

8.4 Half-angle technique without radiation limiter ... 37

8.4.1 Endodontic exposures....................................... 37

9Exposure times........................................................... 39

9.1 HELIODENT DS Serial Nos. 15864 and higher

(wall model) and 4416 and higher

(ceiling model) .................................................. 39

9.2 HELIODENT DS up to Serial No. 15863

(wall model) and 4415 (ceiling model) .............. 40

9.2.1 Exposure times.................................................. 40

9.2.2 Exposure time settings ...................................... 41

10 Care of outer surface ................................................. 45

10.1 Care and cleaning agents ................................ 45

10.2 Cleaning ........................................................... 45

10.3 Disinfecting ....................................................... 46

11 Inspection and maintenance ..................................... 47

11.1 Regular inspection and maintenance ............... 47

11.2 Monthly check performed by the system

owner or authorized persons ............................ 47

11.3 Annual check performed by the system

owner or authorized persons ............................ 47

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Sirona Dental Systems GmbH 1

Operating Instructions and Installation XIOS USB Contents

12 Electromagnetic compatibility .................................. 49

12.1 Accessories ...................................................... 49

12.2 Electromagnetic emission ................................ 49

12.3 Interference immunity ....................................... 49

12.4 Working clearances .......................................... 52

61 77 476 D 3495

6D 3495.201.01.02.02 08.2007

1Sirona Dental Systems GmbH

Contents Operating Instructions and Installation XIOS USB

61 77 476 D 3495

D 3495.201.01.02.02 08.2007 7

Sirona Dental Systems GmbH 1Dear Customer,

Operating Instructions and Installation XIOS USB Contents of this document

1Dear Customer,

Thank you for purchasing your XIOS USB intraoral X-ray system.

The X-ray sensor and USB module enable digital acquisition of intraoral X-ray

images.

A PC with the SIDEXIS XG software installed, version 2.2 and higher, is

required to operate the USB module.

Your XIOS Team

1.1 Contents of this document

Contents These operating and installation instructions describe the handling of the USB

module and the sensor as well as the installation of the system hardware and

software.

1.2 General conventions

General conventions You should familiarize yourself with the unit by reading through the operating

instructions before taking patient exposures. Please always observe the valid

radiation protection directives and the safety information in these

instructions.

These operating instructions are based on the assumption that you are

familiar with the SIDEXIS XG software.

In case you get stuck despite having thoroughly studied the operating

instructions, please contact your dental depot.

To prevent any personal injury or material damage, pay special attention

to any notes printed in bold type or highlighted with signal words such as

NOTICE, CAUTION or WARNING:

1.3 Structure of the documents

Structure of the documents

The symbols and character formats used in the present manual have the

following meaning:

WARNING:

Identifies warnings where a medium risk of injury to persons exists if they are

not observed.

CAUTION:

Identifies safety information where the following hazards exist if they are not

observed: Slight risk of injury to persons, risk of property damage or damage

to the product.

NOTE: Assistance

Identifies additional information, hints and tips.

61 77 476 D 3495

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1Dear Customer, Sirona Dental Systems GmbH

Other valid documents Operating Instructions and Installation XIOS USB

1.4 Other valid documents

In addition to the present document, the following documentation is also

required (not part of the delivery).

zSIDEXIS XG Installation Instructions

zSIDEXIS XG Operator's Manual (for working with SIDEXIS XG software).

Keep these documents handy at all times (file them in the X-ray System

Logbook in the FR of Germany).

Within the Federal Republic of Germany, the attached Declaration of

Conformity with the Medical Device Directive must be filled out by the system

integrator.

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.

9Prerequisite

¾Action

¾1., 2., …

ªResult

Requests you to do something.

See chapter on "General

information".

Identifies a reference to another text

passage.

List Identifies a list.

“Text between

quotation marks“

Identifies commands, menu items or

quotations.

61 77 476 D 3495

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Sirona Dental Systems GmbH 2Warning and safety information

Operating Instructions and Installation XIOS USB

2Warning and safety information

Symbols use d

Symbols used Symbols used

Observe accompanying documents (on rating plate)

Intended use

Intended use This system is intended for generating panoramic or cephalometric X-ray

images.

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

Maintena nce and service r ecommendat ions

Maintenance and service

recommendations

Inspection and 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. In conformity with

IEC 601-1 (DIN EN 60601-1 etc.).

The system owner is responsible for making sure that all scheduled

inspections and preventive maintenance activities are performed.

In the event that the system owner fails to fulfill the obligation to perform

scheduled inspections and preventive maintenance activities or ignores error

messages, Sirona Dental Systems GmbH and its authorized dealers cannot

assume any liability for damages.

As manufacturers of medical electrical equipment, we can assume

responsibility for the safety properties of the system only if maintenance and

repairs on the system are performed by us or by agencies we have expressly

authorized to perform these and if components affecting safe operation of the

system are replaced by original spare parts in case of failure.

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.

Modifications to the system

Modifications to the system 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.

CAUTION! PC extensions can lead to impairment of the system’s functional

reliability (e.g. patient safety and electromagnetic compatibility). The

guarantee of the system’s functional reliability shall automatically be

transferred to anyone who implements a system extension which has not

been expressly approved by Sirona.

Combin ation with other equi pment

Combination with other equipment Permissible combinations are specified in the Declaration of Conformity by

the system integrator.

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2Warning and safety information Sirona Dental Systems GmbH

Operating Instructions and Installation XIOS USB

Patient envi ronment

Patient environment

Within the patient environment (A), direct contact is only permissible with

devices or system parts that are approved for use in the patient environment

(A).

This applies to all possible patient positions (B) during the examination or

treatment.

X-ra yin g of pati en ts

X-raying of patients X-rays of patients may be taken only when the system is functioning perfectly.

The system may only be operated by skilled or properly trained

personnel.

Do not leave the patient at the unit unattended.

Electromagne tic compatib ility (EMC)

Electromagnetic compatibility

(EMC)

The XIOS Intraoral System complies with the requirements of IEC 60601-1-

2:2001.

1500mm

59”

1500mm

59”

1500mm

59”

1500mm

59”

1500mm

59”

1500mm

59”

1500mm

59” 1500mm

59”

1500mm

59”

1500mm

59”

1500mm

59”

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