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61 77 476 D 3495
D 3495

.

201.01.02

.

02

08.2007

49

Sirona Dental Systems GmbH

12

 

Electromagnetic compatibility

Operating Instructions and Installation

 

XIOS USB

Accessories

12

Electromagnetic compatibility

12.1

Accessories

 

z

The UNIT may be operated only with accessories and spare parts 
approved by Sirona. Unapproved accessories and spare parts may lead 
to an increased emission of or a reduced immunity to interference.

z

The UNIT should not be operated immediately adjacent to other devices. 
If this proves to be unavoidable, the UNIT should be monitored to ensure 
that it is used properly.

12.2

Electromagnetic emission

The 

UNIT

 is intended for operation in the electromagnetic environment 

specified below. 

The customer or user of the 

UNIT

 should make sure that it is used in such an 

environment.

 

12.3

Interference immunity

The 

UNIT

 is intended for operation in the electromagnetic environment 

specified below.

 NOTE:  

XIOS complies with the requirements for electromagnetic compatibility 
(EMC) according to IEC 60601-1-2:2001 

XIOS is referred to in the following as "UNIT". Observance of the following 
information is necessary to ensure safe operation regarding EMC aspects.

Designation of the interface cables 

Order No. 

PC as peripheral device

USB hub

USB cable, 3m

61 77 401

Emission measurement

Conformity

Electromagnetic environment – guidelines

RF emissions according to 

CISPR 11

Group 1

The 

UNIT 

uses RF energy only for its internal 

function. Therefore, its RF emissions are very low and 
are not likely to cause any interference in nearby 
electronic equipment.

RF emissions according to 

CISPR 11

Class B

The 

UNIT 

is intended for use in all facilities, including 

residential areas and in any facilities connected 
directly to a public power supply providing electricity 
to buildings used for residential purposes.

Harmonics 
according to

 IEC 61000-3-2

Class A

Voltage fluctuations/flicker according to  

IEC 61000-3-3

Complies

Summary of Contents for XIOS

Page 1: ...uflp rp_ l f f k W MUKOMMT b...

Page 2: ...61 77 476 D 3495 2 D 3495 201 01 02 02 08 2007 1 Sirona Dental Systems GmbH Operating Instructions and Installation XIOS USB...

Page 3: ...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 4 Operating and disp...

Page 4: ...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 exposur...

Page 5: ...2007 5 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...

Page 6: ...61 77 476 D 3495 6 D 3495 201 01 02 02 08 2007 1 Sirona Dental Systems GmbH Contents Operating Instructions and Installation XIOS USB...

Page 7: ...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 familia...

Page 8: ...ile 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 syst...

Page 9: ...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 h...

Page 10: ...ll possible patient positions B during the examination or treatment X raying of patients X raying of patients X rays of patients may be taken only when the system is functioning perfectly The system m...

Page 11: ...ent s body Disturbance of electronic devices worn on the patient s body To prevent the malfunctioning of electronic devices and data memories e g radio controlled watches telephone cards etc these obj...

Page 12: ...igher arc over The transient currents resulting from these discharges have a magnitude of 10 amperes They are not hazardous for humans because they last for only several nanoseconds Background informa...

Page 13: ...nsors Original language of the present document German This product bears the CE mark in accordance with the provisions of the Council Directive 93 42 EEC of June 14 1993 concerning medical devices Pa...

Page 14: ...ress of water Year of manufacture on the rating plate Dimensions H x W x L in mm 132 x 80 x 37 Weight 104 g USB port of USB module Version 2 0 or 1 1 USB Version 2 0 A USB Universal Serial Bus is a se...

Page 15: ...XP at least 256 MB Drives CD ROM writer Operating system Windows XP Graphics system Resolution at least 1024 x 768 pixels Color depth at least 16 bits USB port of PC system Version 1 1 or 2 0 Safety T...

Page 16: ...nstallation XIOS USB 3 8 Requirements for the USB hub optional Type of protection against electric shock Protection class II USB standard USB 1 1 or higher Power supply Separate power supply not bus p...

Page 17: ...ting and display elements 4 1 System design To be ready for use a system must include z USB module A z USB cable B z Sensor C with cable and connector size 1 or size 2 z PC D with integrated USB inter...

Page 18: ...lanation The USB module indicates the current operating status via two green and orange LEDs An overview of the different operating statuses is provided here Green LED Green LED display off z The USB...

Page 19: ...ation Instructions and Operator s Manual for SIDEXIS XG as well as the relevant manuals for your PC and its operating system NOTE Installation on multiple SIDEXIS XG PCs The complete installation must...

Page 20: ...a location to connect the protective ground wire on the rear side of the metal casing frame B that is readily accessible from the inside and from the outside 2 Drill a hole with a suitable diameter f...

Page 21: ...a USB module on a PC Prerequisites z The PC is ready for operation z SIDEXIS XG Version 2 2 or higher is installed z Optionally A USB hub has been installed as specified by Sirona Installation 9 Conn...

Page 22: ...b with the supplied USB cable The USB module is now installed 5 3 4 Installation of additional USB modules on a PC Prerequisites z The PC is ready for operation z A USB hub has been installed as speci...

Page 23: ...via internet When activating exposure readiness SIDEXIS XG checks whether the sensor has been installed If the sensor has not yet been installed the user is asked whether it should be installed automa...

Page 24: ...the sensor correction file SGF 8 Copy the sensor correction file SGF to your XIOS computer using e g a USB stick 9 Install the sensor on your XIOS computer by double clicking on the sensor correction...

Page 25: ...61 76 577 Wall holder for XIOS X ray sensors Order No 61 74 879 Test phantom for constancy test of size 1 and size 2 XIOS sensors Order No 61 77 328 USB cable 3 m Order No 61 77 401 XIOS sensor holde...

Page 26: ...structions and Installation XIOS USB XIOS sensor holder endo universal green 100 pcs Order No 61 76 544 XIOS sensor holder endo gray 50 pcs Order No 61 76 551 Radiation limiter 3x4 replacement Order N...

Page 27: ...by registering a patient in SIDEXIS XG 2 To take a single exposure click the intraoral exposure button Exposure readiness is restored automatically Exposure readiness displays z The exposure readines...

Page 28: ...sposable items z Only for the same patient The sensor holder can be removed and reglued repeatedly during a series of exposures even if it already has come into contact with saliva Exposure 1 Before t...

Page 29: ...it on a patient CAUTION Risk of damage Handle the sensor carefully Do not drop the sensor Do not swirl the sensor about by its cable Do not bend the sensor and USB cables or run over them e g with a c...

Page 30: ...tective sleeve with a size that matches the sensor 2 Slide the sensor into the hygienic protective sleeve 3 Position the sensor holder on the hygienic protective sleeve Handling information for the pa...

Page 31: ...ensor facing away from the sensor cable with your thumb 2 Carefully push the sensor out of the part of the hygienic protective sleeve that is glued to the sensor holder with your thumbnail NOTE Leave...

Page 32: ...ona Dental Systems GmbH Hygienic protection Operating Instructions and Installation XIOS USB 3 Slide the sensor further out of the hygienic protective sleeve with your thumb 4 Hold the sensor cable fi...

Page 33: ...he matching localizer ring are color coded blue z The triple offset guide rod and the blue localizer ring for anterior tooth exposures must be used z The following illustrations show how to attach the...

Page 34: ...h exposures z This sensor holder and the matching localizer ring are color coded yellow z The double offset guide rod and the yellow localizer ring for posterior tooth exposures must be used z The fol...

Page 35: ...hygienic protective sleeve following the patient examination 5 The guide rod and localizer ring must be sterilized 8 3 3 Bite wing exposures Explanation The bite tab type sensor holder is available fo...

Page 36: ...the middle of the sensor X ray exposure 1 Position the sensor in the patient s mouth 2 Place the X ray tube assembly in the correct position Change the position of the sensor holder if necessary 3 Re...

Page 37: ...e sensor holder to the hygienic protective sleeve with sensor Preparation 1 Slide the sensor into the hygienic protective sleeve When doing so follow the instructions for sensors 2 Select the green se...

Page 38: ...61 77 476 D 3495 38 D 3495 201 01 02 02 08 2007 8 Use of the X ray sensor Sirona Dental Systems GmbH Half angle technique without radiation limiter Operating Instructions and Installation XIOS USB...

Page 39: ...1 and size 2 XIOS X ray sensors The exposure parameters specified for Sirona X ray sensors in the documentation for the various Sirona intraoral X ray systems therefore do not apply to size 1 and size...

Page 40: ...gher number appears briefly after the unit is switched on Classification of recommended exposure times by tooth region z A adults z B children z C Mandibular anterior tooth z D Mandibular canine tooth...

Page 41: ...terior tooth z F Maxillary molars z G Maxillary canine tooth Mandibular molars z H occlusal exposure If a 12 SSD cone is used together with a size 1 size 2 XIOS X ray sensor the above exposure times a...

Page 42: ...Settings for the 8 cone z Setting for adult patients mandibular maxillary anterior tooth mandibular premolar z Setting for adult patients maxillary premolar mandibular maxillary molar occlusal exposur...

Page 43: ...he 12 cone z Setting for adult patients mandibular maxillary anterior tooth mandibular premolar z Setting for adult patients maxillary premolar mandibular maxillary molar occlusal exposure z Setting f...

Page 44: ...476 D 3495 44 D 3495 201 01 02 02 08 2007 9 Exposure times Sirona Dental Systems GmbH HELIODENT DS up to Serial No 15863 wall model and 4415 ceiling model Operating Instructions and Installation XIOS...

Page 45: ...an order the list in one of the following two ways z Order it from your local dental depot z Order from Sirona Tel 49 0 62 51 16 16 16 Fax 49 0 62 51 16 18 18 Order No 59 70 905 10 2 Cleaning USB modu...

Page 46: ...nly be disinfected by wiping them off z USB module z USB cable z Size 1 and size 2 XIOS X ray sensors Sensors The following should be observed regarding XIOS sensors and their connecting leads z Senso...

Page 47: ...ned securely 11 3 Annual check performed by the system owner or authorized persons Image quality check The image quality should be assessed by the system owner at regular intervals at least once a yea...

Page 48: ...D 3495 48 D 3495 201 01 02 02 08 2007 11 Inspection and maintenance Sirona Dental Systems GmbH Annual check performed by the system owner or authorized persons Operating Instructions and Installation...

Page 49: ...in the electromagnetic environment specified below NOTE XIOS complies with the requirements for electromagnetic compatibility EMC according to IEC 60601 1 2 2001 XIOS is referred to in the following...

Page 50: ...ltages according to IEC 61000 4 5 1 kV differential mode 2 kV common mode voltage 1 kV differential mode 2 kV common mode voltage The quality of the line power supply should be that of a typical comme...

Page 51: ...repositioning of the UNIT 3 Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m Portable and mobile radio equipment must not be used within the recommended working clear...

Page 52: ...the relevant communication device as specified below For transmitters whose maximum nominal output is not specified in the above table the recommended working clearance d in meters m can be determined...

Page 53: ...61 77 476 D 3495 D 3495 201 01 02 02 08 2007 53 Sirona Dental Systems GmbH 12 Electromagnetic compatibility Operating Instructions and Installation XIOS USB Working clearances...

Page 54: ...t K p a p d e OMMT p W m d a PQVRKOMNKMNKMOKMO MUKOMMT KJk KW NMU UPO f p a p d e rp W W c PN SQSOR _ d K K p a p ii QUPR p a I p NMM I k OUOTP rp p PORM o a J r R j I l iRi RvS l k SN TT QTS a PQVR...

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