KaVo ProXam iS Instructions For Use Manual Download Page 6

3  Symbols

Type BF equipment (Standard IEC 60601-1).

Medical Device

Consult electronic instructions for use (Standard ISO 7000-1641).

Attention, consult accompanying documents (Standard IEC 60601-1).

The use of accessory equipment not complying with the equivalent

requirements of this equipment may lead to a reduced level of safety of

the resulting system. Consideration relating to the choice shall include:

use of the accessory in the Patient Vicinity

evidence that the safety certification of the accessory has been

performed in accordance to appropriate IEC60601 and/or IEC60601-1-1

harmonized national standard.

Planmeca ProSensor is ETL classified and conforms to ANSI/AAMI

ES60601-1 and is certified to CAN/CSA C22.2 No. 60601.1.

Separate collection for electrical and electronic equipment according to

Directive 2002/96/EC (WEEE)

 

3143029

ETL CLASSIFIED

3  Symbols

2 KaVo ProXam iS

Instructions for use

Summary of Contents for ProXam iS

Page 1: ...KaVo ProXam iS Instructions for use EN...

Page 2: ...to the appropriate requirements such as IEC 60364 equipment is used according to the operating instructions Planmeca pursues a policy of continual product development Although every effort is made to...

Page 3: ...l 14 8 1 Quality check using SMPTE test pattern 14 9 Sensor holders 14 10 Cleaning and disinfection 15 10 1 Sensors and cables 15 10 2 Sensor holders 15 10 3 Control box 16 11 Service 17 12 Terms and...

Page 4: ...Table of contents KaVo ProXam iS Instructions for use...

Page 5: ...ird party software stating compatibility with KaVo ProXam iS or software stating compatibility through TWAIN can be used for image capturing KaVo ProXam iS is connected to a computer using Ethernet or...

Page 6: ...Consideration relating to the choice shall include use of the accessory in the Patient Vicinity evidence that the safety certification of the accessory has been performed in accordance to appropriate...

Page 7: ...lling over it with a chair or walking over it CAUTION Do not store or use the digital sensor near 3m or 10 ft an electrosurgical knife CAUTION Do not unnecessarily touch the connector pins to keep the...

Page 8: ...g serious incidents Serious incidents that have occurred in relation to the device must be reported to the manufacturer and the local competent authority 4 Safety precautions 4 KaVo ProXam iS Instruct...

Page 9: ...en and image is transferred from the sensor to the control box Steady red Error mode Slowly flashing yellow Service mode Uploading control box software Slowly flashing blue turns to slowly flashing di...

Page 10: ...tact 6 1 Positioning patient Ask the patient to sit down Place a protective lead apron over the patient s chest 6 2 Preparing and positioning sensor Before each use on a patient make sure the sensor h...

Page 11: ...que recommended Place the sensor 2 to a sensor holder and align the holder parallel to the long axis of the tooth 1 Use a long cone for the paralleling technique 6 Before exposure Instructions for use...

Page 12: ...t or an unmodified Snap a ray holder Make sure the digital sensor system is ready for the exposure and communicates with Romexis refer to section Control box indicator light on page 5 On how to place...

Page 13: ...ND I P M I INCISORS M MOLARS P PREMOLARS AND CANINES Long cone 30 cm 12 exposure values Jaw mA TIME 0 010s 0 012s 0 016s 0 020s 0 025s 0 032s 0 040s 0 050s 0 063s 0 080s 0 100s 0 125s 0 160s 0 200s 0...

Page 14: ...ars on top of the window 2 Prepare the patient for exposure select exposure parameters and position the intraoral X ray unit as required for more information refer to the unit s user s manual Instruct...

Page 15: ...g images into study template About this task The images are captured into study templates containing a predefined set of multiple images Steps 1 Click the intraoral exposure with study button on the m...

Page 16: ...eters and position the intraoral X ray unit as required for more information refer to the unit s user s manual Instructions for use NOTE Inform the patient that the sensor may feel warm in the mouth W...

Page 17: ...upper right corner of the sensor when positioned as illustrated with the cable running on the backside of the sensor To cancel the process click Cancel The captured images are saved and the incomplete...

Page 18: ...smpte org and follows the SMPTE Recommended Practise RP 133 1991 Specifications for Medical Diagnostic Imaging Test Pattern for Television Monitors and Hard Copy Recording Cameras This image should b...

Page 19: ...atory to carefully follow the cleaning and disinfection recommendations for not to damage the sensors CAUTION The sensors cannot be sterilized in autoclave or UV oven Wipe the sensor surface with a so...

Page 20: ...UTION Switch off the unit before cleaning NOTE Do not disinfect the unit CAUTION Never detach the control box ethernet cable without releasing the latch on the cable connector Forcefully detaching the...

Page 21: ...in a technical bulletin must be installed on the X ray unit KaVo Technical Service If you have any questions or complaints please contact the KaVo Technical Service 49 0 7351 56 2900 service xray kavo...

Page 22: ...specifications The warranty does not usually cover bulbs glassware rubber parts software scanner tips batteries tubes screws nuts and other fasteners imaging plates and the colourfastness of plastics...

Page 23: ...accordance with waste legislation and instructions issued by the environmental authorities The risks involved and the necessary precautions must be taken into account when handling waste products Part...

Page 24: ...x 26 1 mm 1 42 x 1 03 in pixel matrix 2400 x 1740 number of pixels 4 18 M Image sizes Size 0 850 x 629 0 5 MP 1700 x 1258 2 14 MP Size 1 1020 x 690 0 7 MP 2040 x 1380 2 82 MP Size 2 1200 x 870 1 0 MP...

Page 25: ...ing requirements according to radiation safety regulation in the country The system is used by dental care professionals Prior to installation of the system check that the local conditions are compati...

Page 26: ...Manufacturer Planmeca Oy Asentajankatu 6 FIN 00880 Helsinki Finland Phone 358 20 7795 500 Fax 358 20 7795 555 http www planmeca com 14 Technical specification 22 KaVo ProXam iS Instructions for use...

Page 27: ...ild Maxilla 60 8 0 063 60 8 0 08 60 8 0 1 Mandible 0 050 0 063 0 08 OCCLUSAL ENDODONTIC BITE WING kV mA time kV mA time kV mA time Adult Maxilla 70 8 0 08 60 8 0 08 60 8 0 125 Mandible Child Maxilla 6...

Page 28: ...USAL ENDODONTIC BITE WING kV mA time kV mA time kV mA time Child Maxilla 66 8 0 125 60 8 0 125 60 8 0 2 Mandible Appendix A Exposure value tables for KaVo ProXam iX 24 KaVo ProXam iS Instructions for...

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Page 30: ...KaVo Dental GmbH Bismarckring 39 88400 Biberach Deutschland www kavo com 1 015 1195...

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