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61 97 102 D3495

6

D3495

.

201.03.07

.

02 08.2011

2 Warning and safety information

Sirona Dental Systems GmbH

Operating Instructions XIOS

Plus

Sensors

2

Warning and safety information

Warning and safety information

Symbols used

Symbols used

Observe accompanying documents (on rating plate)

Intended use Intraoral

Intended use

This product has been designed for the digital acquisition of intraoral X-

ray images.
This product must not be used in areas subject to explosion hazards.
Indications in the areas:

Intraoral indication

● 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:

Intraoral contraindication

● Display of cartilage structures
● Display of soft tissue

Restriction of customers (USA)

USA only: Caution!

According to US Federal Law, this product may be sold only to or by

instruction of physicians, dentists, or licensed professionals.

Maintenance and service recommendations

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

accordance with IEC 60601-1.
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

Systems GmbH and its authorized dealers cannot assume any liability for

resulting damage.
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 authorized by us, and if components affecting safe operation of

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

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Содержание XIOS Plus

Страница 1: ...MUKOMNN uflpmäìë pÉåëçêë kÉï ë çÑW båÖäáëÜ léÉê íáåÖ fåëíêìÅíáçåë Cover page ...

Страница 2: ...description 12 3 1 General data 12 3 2 Sensors 12 3 3 Ambient conditions 12 3 4 Requirements for intraoral X ray tube assemblies 13 4 Accessories and spare parts 14 4 1 Accessories 14 5 Use of the X ray Sensor 17 5 1 Preparation 17 5 2 Hygienic protection 18 5 2 1 General information 18 5 2 2 Sliding the hygienic protective sleeve over the sensor 19 5 2 3 Removing the hygienic protective sleeve fr...

Страница 3: ...posure times 27 6 1 HELIODENT DS 28 6 1 1 HELIODENT DS Serial Nos 15864 and higher wall model and 4416 and higher ceiling model 28 6 1 2 HELIODENT DS up to Serial No 15863 wall model and 4415 ceiling model 30 7 Care of outer surface 32 7 1 Care and cleaning agents 32 7 2 Disinfecting 32 7 3 Sterilizing 33 8 Configuration 36 ...

Страница 4: ...structions 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 ...

Страница 5: ... XG Operator s Manual for working with SIDEXIS XG software included in delivery SIDEXIS XG X ray system book Keep these documents handy at all times file them in the X ray System Logbook in Germany The system integrator must complete the enclosed declaration of conformity To safeguard your warranty claims please complete the attached Installation Report Warranty Passport together with the service ...

Страница 6: ...on According to US Federal Law this product may be sold only to or by instruction of physicians dentists or licensed professionals Maintenance and service recommendations 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 use...

Страница 7: ...a 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 will automatically be transferred to anyone who implements a system extension wh...

Страница 8: ...ssible patient positions B during the examination or treatment X raying of patients X raying of patients X rays of patients must be taken only when the system works without errors The system may only be operated by skilled or properly trained personnel Do not leave the patient at the unit unattended Changes to unit X raying of patients XIOS Plus Sensor Operating Instructions Use the XIOSPlus senso...

Страница 9: ...tween patients users and other persons The sensors and the cable must be wiped disinfected before each patient Disturbance of electronic devices worn on the patient 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 objects must be removed prior to the X ray...

Страница 10: ...r coverings The following rule of thumb can be applied to assess the transient voltages resulting from an electrostatic discharge An electrostatic discharge is perceptible at 3 000 V or higher audible at 5 000 V or higher cracking crackling visible at 10 000 V or higher arc over The transient currents resulting from these discharges have a magnitude of 10 amperes They are not hazardous for humans ...

Страница 11: ...ems GmbH 2 Warning and safety information Operating Instructions XIOSPlus Sensors 2 2 About the physics of electrostatic charges båÖäáëÜ To prevent this from happening the ESD warning label next to the plug warns of this hazard ESD stands for ElectroStatic Discharge ...

Страница 12: ...nt conditions Original language of the present document German Patents US 5 912 942 US 5 434 418 US 6 811 312 US 6 069 935 US 6 134 298 US 5 841 126 US 6 549 235 US 6 570 617 US 5 513 252 Additional patents pending Technology CMOS APS Active Pixel Sensor Physical pixel size 15 µm Active surface Size 1 sensor 20 x 30 mm Size 2 sensor 25 6 x 36 mm The active surface of the sensor is identified by do...

Страница 13: ...ge and transport 500 1060 hPa Air pressure operation 700 1060 hPa Operating altitude 3000 m Multipulse units DC mAs product 0 14 1 4 mAs at 60 70 kV and 8 cone This information must be modified accordingly for single pulse units or other cone lengths NOTICE The intraoral X ray tube assembly must be installed in accordance with the manufacturer s instructions and requirements Please refer to the ma...

Страница 14: ...including localizer ring and guide rod 15x sensor holder tab endo gray including localizer ring and guide rod 15x sensor holder tab universal green 50x hygienic protective sleeves size 2 XIOS Plus sensor holder starter kit size 1 Order No 61 73 632 Contents 15x sensor holder tab anterior blue including localizer ring and guide rod 15x sensor holder tab posterior yellow including localizer ring and...

Страница 15: ...XIOSPlus Hygienic protective sleeves size 1 single use device 300 pcs Size 1 Order No 61 48 998 Size 2 Order No 61 49 004 Wall holder for XIOS X ray sensors Order No 61 74 879 Phantom XIOSPlus sensor sizes 1 and 2 for constancy test only for Germany Order No 62 09 634 XIOS sensor holder tab anterior blue single use device 100 pcs Order No 61 76 510 XIOS sensor holder tab posterior yellow single us...

Страница 16: ...ctions XIOSPlus Sensors XIOS sensor holder tab endo gray single use device 50 pcs Order No 61 76 551 XIOS sensor holder tab universal green single use device 100 pcs Order No 61 76 544 Radiation field limiter 3x4 for HELIODENT DS replacement Order No 46 81 974 Radiation field limiter 2x3 for HELIODENT DS replacement Order No 60 00 579 ...

Страница 17: ...r the sensor before using it on a patient NOTICE 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 cables or run over them e g with a chair Avoid laying sensor cables on the floor if possible Make sure that the patient does not bite on the sensor or the sensor cable NOTICE Operational reliability The sensor must be c...

Страница 18: ...protective sleeve for sensor size 1 300 pcs Order No 62 01 839 XIOSPlus hygienic protective sleeve for sensor size 2 300 pcs Order No 62 01 847 Sensor NOTICE Check all adhesive labels at regular intervals and at least once a month to make sure that they are intact legible and properly affixed Also check the acquisition unit i e XIOSPlus USB module or XIOSPlus wall module and the cables connected t...

Страница 19: ...cted sensor 5 2 3 Removing the hygienic protective sleeve from the sensor Removing the hygienic protective sleeve from the sensor NOTICE Size of the hygienic protective sleeve The hygienic protective sleeve is slightly undersized so that it surrounds the sensor tightly and prevents the sensor from slipping out of place NOTICE The exact position depends on the sensor holder tab used and the X ray e...

Страница 20: ...us Sensors 1 Grasp the guide rod in one hand so that you can touch the side of the sensor 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 tab with your thumb 3 Slide the sensor further out of the hygienic protective sleeve with your thumb ...

Страница 21: ...ior tooth exposure Explanation A special anterior sensor holder tab is available for anterior tooth exposures This sensor holder tab and the matching localizer ring are color coded blue The triple offset guide rod and the blue localizer ring for anterior tooth exposures must be used The following illustrations show how to attach the sensor holder tab to the hygienic protective sleeve with sensor P...

Страница 22: ... 5 The guide rod and localizer ring must be cleaned and sterilized 5 3 2 Posterior tooth exposures Posterior tooth exposures Explanation The posterior type sensor holder tab is available for periapical posterior tooth exposures This sensor holder tab and the matching localizer ring are color coded yellow The double offset guide rod and the yellow localizer ring for posterior tooth exposures must b...

Страница 23: ...or is identified by dots on the sensor The edge of the sensor holder tab must be flush with the edge of the sensor X ray image 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 Release an X ray exposure 4 Discard the sensor holder tab and the hygienic protective sleeve following the patient e...

Страница 24: ...own in the illustration The active area of the sensor is identified by dots on the sensor 5 For horizontal bite wing exposures Position the sensor holder tab horizontally on the hygienic protective sleeve in the middle of the active area of the sensor as shown in the illustration The active area of the sensor is identified by dots on the sensor X ray image 1 Position the sensor in the patient s mo...

Страница 25: ...position of the sensor holder if necessary 3 Release an X ray exposure 4 Discard the sensor holder tab and the hygienic protective sleeve after completing the root treatment 5 The guide rod and localizer ring must be disinfected 5 4 Half angle technique without radiation limiter Half angle technique without radiation limiter Depending on the size of the tooth or position of the area to be exposed ...

Страница 26: ...ensor holder tab on the edge of the sensor near the cable 4 Posterior tooth exposures To take posterior tooth exposures position the sensor holder tab in the middle of the active area of the sensor The active area of the sensor is identified by dots on the sensor X ray image 1 Position the sensor in the patient s mouth 2 Place the X ray tube assembly in the correct position Change the position of ...

Страница 27: ...rocessing function independent of dose XIOSPlus sensors have a very wide effective dose area so that depending on the object and diagnostic question at hand the selection of an optimal parameter adjustment is always possible Exposure times for size 1 and size 2 XIOSPlus X ray sensors Short exposure times are adequate for the highly sensitive size 1 and size 2 XIOSPlus X ray sensors The exposure pa...

Страница 28: ...For a detailed description please refer to the Operating Instructions of the HELIODENT DS 6 1 1 HELIODENT DS Serial Nos 15864 and higher wall model and 4416 and higher ceiling model HELIODENT DS Serial Nos 15864 and higher wall model and 4416 and higher ceiling model Possible exposure times Recommended exposure times with 8 SSD cone and XIOS size 1 size 2 X ray sensors An excellent image quality i...

Страница 29: ...d automatically Each tooth symbol is subdivided into three different exposure times For digital X ray exposures make sure to set the longest exposure time setting within a tooth symbol for X rays of adults and the shortest exposure time setting for X rays of children Only then does the corresponding value appear on the digital display Adjacent example Maxillary molar Valid for software version 17 ...

Страница 30: ... of the sensors using the parallel technique with XIOSPlus sensor holders ensures an optimal positioning of the sensors in the beam path of the cone It is the responsibility of each individual dentist to determine the required dose for each patient in order to achieve image quality suitable to make a diagnosis Sirona can only make recommendations Classification of exposure times Classification of ...

Страница 31: ...tems GmbH 6 Exposure times Operating Instructions XIOSPlus Sensors 6 1 HELIODENT DS båÖäáëÜ G Maxillary canine tooth Mandibular molars 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 are doubled ...

Страница 32: ...and cleaning agents supplement for USA Care and cleaning agents supplement for USA The outside areas may be disinfected with a suitable chemical disinfectant Only use disinfectants that meet the requirements of the national authorities and have been tested and certified for the necessary bactericidal fungicidal and virucidal properties Examples of approved disinfectants are MinutenSpray classic by...

Страница 33: ...Then dry the sensor and cable with a fiber free cloth or paper towel Disinfection 1 Wipe the sensor and cable completely and thoroughly at least twice with one of the disinfectants recommended in the section Care and cleaning agents 2 Remove any chemical residues by wiping off the sensor with a moist cloth or gauze 3 Dry the sensor and the cable with a fiber free cloth if necessary 4 Store the sen...

Страница 34: ...ilization Operate the autoclave according to the manufacturer s instructions the conditions for sterilization are specified below NOTICE Risk of damage Please follow the instructions given below carefully Otherwise your components the autoclaves or any other objects you have placed in the autoclaves may be damaged NOTICE Durability of plastic parts Plastic parts have a limited durability and there...

Страница 35: ...erilized contents packed loosely Sterilizer temperature pressure length of cycle Steam sterilizer 121 C 103 4 kPa 250 F 15 psi 20 minutes or Steam sterilizer 132 206 8 kPa 270 F 30 psi 8 minutes Sterilized contents packed tightly Sterilizer temperature pressure length of cycle Steam sterilizer 121 C 103 4 kPa 250 F 15 psi 20 minutes or Steam sterilizer 132 C 206 8 kPa 270 F 30 psi 10 minutes ...

Страница 36: ...er 3 Selection field Brightness The brightness can be corrected here Selection field Contrast The contrast can be corrected here Binning area The modifications made in this area will be processed for each X ray exposure Binning is the technique of combining neighboring pixels to one single pixel The more pixels that are combined the lower the image noise In contrast the resolution of the system de...

Страница 37: ...r check box Activation of the Orientation marker check box causes the position of the XIOSPlus sensor to be retained during the exposure this is achieved with the displayed sensor size Marking of sensor sizes 1 sensor size 1 2 sensor size 2 The sensor size is displayed on the XIOSPlus sensor on which the name SIRONA is located For example a mirror inverted 1 or 2 shows that the image was mirror in...

Страница 38: ...áêçå aÉåí ä póëíÉãë dãÄe OMNN péê ÅÜÉW ÉåÖäáëÅÜ mêáåíÉÇ áå dÉêã åó aPQVRKOMNKMPKMTKMO MUKOMNN ûKJkêKW NNQ RVS páêçå aÉåí ä póëíÉãë dãÄe áå íÜÉ rp W c Äêáâëíê É PN SQSOR _ÉåëÜÉáã dÉêã åó ïïïKëáêçå KÅçã páêçå aÉåí ä póëíÉãë ii QUPR páêçå aêáîÉI pìáíÉ NMM Ü êäçííÉI k OUOTP rp lêÇÉê kç SN VT NMO aPQVR ...

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