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7 Technical data

214760 rev 1

KaVo Dental GmbH

7 Technical data

7.1 Technical specifications

Manufacturer:

Instrumentarium Dental,

PaloDEx Group Oy,

Nahkelantie 160

FI-04300 Tuusula, FINLAND

Manufacturer’s Quality System:

In accordance with ISO13485 and

ISO9001 standard

Environmental Management
System:

In accordance with ISO 14001

standard

Conformity to standards:

IEC 60601-1

IEC 60601-1-4

IEC 60601-1-3

IEC 60601-2-7

IEC 60601-2-28

IEC60601-2-65

CAN/CSA –C22.2 No. 601-1-M90

CE models marked according to

the Medical Device Directive 93/

42/ EEC

Product Name

FOCUS™

intraoral x-ray

Type

FOCUS

UNIT DATA

Protection against electric
shock

Class I

Degree of protection

Type B

Protection against the ingress
of liquids

IP20

Mode of operation

Continuous operation with

intermittent loading

Power supply

Mains connection, plug or fixed

Software version

3.0 or higher

X-RAY GENERATOR

Generator type

Constant potential

Nominal power

490 W

High voltage

Supply frequency

100-200 kHz

Number of phases

Reference current time product

7 mAs (70 kV, 7 mA, 1 s)

Lowest current time product

0.14 mAs (70 kV, 7 mA, 0.02 s)

Coefficient of variation of DAP

< 0,05

Содержание 214760

Страница 1: ...FOCUS Intraoral X ray User Manual ENGLISH 214760 rev 1 0 805 4936...

Страница 2: ......

Страница 3: ...are property of their respective owners Documentation trademark and the software are copyrighted with all rights reserved Under the copyright laws the documentation may not be copied photocopied repro...

Страница 4: ......

Страница 5: ...t 7 3 1 Precautionary actions for safe use 7 3 2 Switching the power on off 7 3 3 Selecting the cone 8 3 4 Selecting the exposure parameters 8 3 5 Positioning the patient 10 3 6 Taking an exposure 12...

Страница 6: ...ii KaVo Dental GmbH 214760 rev 1...

Страница 7: ...ogrammed if needed Other user settings include selecting 60 or 70 kV setting exposure times between 0 02 and 3 2 seconds and pediatric or adult modes Exposures can be made directly from the remote con...

Страница 8: ...unit The following symbols are used in the unit Name and address of the manufacturer Serial number X ray source assembly emitting Radiation warning Radiation generating unit Focal spot Filtration Con...

Страница 9: ...er of a licensed healthcare practitioner Do not reuse Recyclable Stacking limit Max 4 transportation packages may be vertically stacked CE 0537 symbol MDD 93 42 EEC ETL Mark Conforms to UL STD 60601 1...

Страница 10: ...ated on the under side of the horizontal arm and in the tube HV generator housing assembly label on the tube head The unit is class I type B and with IP 20 protection The focal length is defined in th...

Страница 11: ...1 Introduction 214760 rev 1 KaVo Dental GmbH 5 1 6 Labels on the unit Labels on the picture are for reference purposes only Actual texts may not be accurate...

Страница 12: ...le and mobile RF communications equipment can interfere with operation of the medical electrical equipment The unit is available with three different arm length configurations Each unit is equipped wi...

Страница 13: ...MOUNT PLATES Wall mount plate for single stud Wall mount plate for 16 center studs ACCESSORIES Short cone round Short cone rectangular Long cone round Long cone rectangular Long full metal rectangula...

Страница 14: ...is also recommended to provide the patient with a protective apron Consult the physician before taking images of pregnant patients WARNING The unit must not be used in rooms where explosive hazards ex...

Страница 15: ...fied FOCUS intraoral x ray dental dealer Original or authorized spare parts are used If service on the unit is performed a work order describing the type and extent of repair must be provided by the s...

Страница 16: ...ional specifications despite proper maintenance and repair then the unit is no longer serviceable and should be replaced Follow all regulations on disposal of waste parts The unit has at least the fol...

Страница 17: ...standard Wide wall mount Adapter for Gendex Expert DC footprint Adapter for KaVo treatment units 2 Connection box Mains wiring Universal power 115V 230V 3 Horizontal arm Options short medium extra lon...

Страница 18: ...hort cone round Short cone rectangular Long cone round Long cone rectangular Short full metal rectangular cone Long full metal rectangular cone 7 Remote control with cable 2 2 Cones Short cone round S...

Страница 19: ...2 Unit description 214760 rev 1 KaVo Dental GmbH 3 Short full metal rectangular cone Long full metal rectangular cone...

Страница 20: ...Maxillary cuspid Maxillary incisors Bitewing Mandibular molar Mandibular cuspid Mandibular incisors Occlusal Exposure button X ray source assembly emitting Ready for exposure Patient Size Selection D...

Страница 21: ...2 Unit description 214760 rev 1 KaVo Dental GmbH 5 Exposure time control...

Страница 22: ...2 Unit description 6 KaVo Dental GmbH 214760 rev 1...

Страница 23: ...nt and any exposed electrical connectors simultaneously 3 2 Switching the power on off The power switch is located on the bottom of the access block Turn the switch to the ON I position to switch the...

Страница 24: ...rotating it and pulling it out Then push and rotate the new cone in NOTICE Make sure that the values set in the programming mode correspond to the cone length and shape 3 4 Selecting the exposure par...

Страница 25: ...other tooth button light indicators will be off 5 The exposure time may be adjusted manually with the UP and DOWN buttons The exposure time is based on the tooth type patient size exposure mode film...

Страница 26: ...aim the beam towards the film sensor observing the correct angle of the beam The horizontal angle of the cone is indicated on the scale located around the vertical joint of the tube head NOTICE Always...

Страница 27: ...achievable 4 Instruct the patient to avoid any movement during the exposures WARNING Take care not to hit the patient with the unit during the positioning of the patient NOTICE If the resulting image...

Страница 28: ...blank during the exposure and will reflect the elapsed time of the actual exposure afterwards NOTICE When using the system in an extremely high electromagnetic environment interferences may change im...

Страница 29: ...ing mode the display will show the updated exposure time Menu Selections Display Contents Film Speed Pr1 fast film Speed F SF fast film Ekta speed E SE slow film Ultra speed D Sd Cone selection Pr2 sh...

Страница 30: ...tons have been preprogrammed by the factory but can be changed if necessary by the user First increase or decrease the exposure time with UP and DOWN buttons Then press and hold the corresponding toot...

Страница 31: ...REH failure Contact the service E4 Tube head too hot or too cold Wait for valid tube head temperature E5 Line voltage low Contact the service E6 not in use N A Contact the service E7 EEPROM failure Co...

Страница 32: ...5 Error messages 16 KaVo Dental GmbH 214760 rev 1...

Страница 33: ...t coagulation and thus facilitate the removal of protein substances Then wipe with a cloth moistened in clear water Mild detergent solution can be used Never use solvents of any kind If you are uncert...

Страница 34: ...ould be immediately reported to your dealer WARNING Only trained and qualified personnel should be permitted to access the internal parts of the unit CAUTION After the operation in the service mode th...

Страница 35: ...place a radiation detector not supplied with the unit on the test object and position the cone of the unit on the radiation detector Recommended technique factors for conducting this test are 70 kV 0...

Страница 36: ...ward on the fuse base and twist it counterclockwise with a screwdriver The fuse with the base will come out Remove the fuse from the base and replace it with the new one Repeat this with each blown fu...

Страница 37: ...1 M90 CE models marked according to the Medical Device Directive 93 42 EEC Product Name FOCUS intraoral x ray Type FOCUS UNIT DATA Protection against electric shock Class I Degree of protection Type...

Страница 38: ...Focal spot 0 7 mm according to IEC 60336 2005 Nominal anode input power 940 W Max symmetrical radiation field 60 mm at a 200 mm focal length Total filtration 2 0 mm Al 70 kV Inherent filtration 1 5 m...

Страница 39: ...m 12 inches Installation Standard wall mount Optional base for free standing unit Height x Width x Depth mm Unit 1059 mm x 279 mm x 946 1096 1346 mm Tube head assembly 112 mm x 260 mm x 201 mm Weight...

Страница 40: ...69 7 29 4 38 9 29 0 38 9 16 4 21 7 0 400 65 2 87 4 36 7 48 9 36 3 48 7 20 5 27 2 0 500 81 7 109 7 45 9 61 1 45 5 61 1 25 6 34 1 0 630 103 0 138 1 57 8 77 1 57 4 76 9 32 2 42 9 0 800 130 7 175 5 73 2 9...

Страница 41: ...nt guidance RF emissions 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 electron...

Страница 42: ...EC 61000 4 5 r1 kV differential mode r2 kV common mode r1 kV differential mode r2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short i...

Страница 43: ...gths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment...

Страница 44: ...ter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10...

Страница 45: ...limiting device EQUIPMENT STATEMENT FOR TUBE HOUSING ASSEMBLY Art No Part number Cones Program Mode Pr2 Cone type ID 0 805 0057 50410 img Long cone round 60 mm SSD 12 305 mm 3 0 805 0058 50420 img Lon...

Страница 46: ...ly wired hospital grade outlet WARNING If the unit needs to be connected to a multiple socket outlet it shall not be placed on the floor WARNING Multiple extension cables shall not be used WARNING The...

Страница 47: ...8 User s statement 214760 rev 1 KaVo Dental GmbH 31 TUBE RATINGS TUBE HEAD COOLING CURVE Fig 8 1 Maximum Rating Chart D 0711SB or D 0711S...

Страница 48: ...8 User s statement 32 KaVo Dental GmbH 214760 rev 1 Fig 8 2 Tube anode thermal characteristics D 0711SB or D 0711S TUBE HEAD THERMAL CHARACTERISTICS Fig 8 3 Tube head assembly cooling curve...

Страница 49: ...TLINE OF THE TUBEHEAD Fig 8 4 Tubehead dimensions and the location of the focal spot Exp time Wait time Exp time Wait time 0 02s 10s 0 32s 10s 0 03s 10s 0 40s 10s 0 04s 10s 0 50s 10s 0 05s 10s 0 63s 1...

Страница 50: ...gh voltage peak value measured over the high voltage feedback resistor with a calibrated voltage device mA The tube current mean value calculated by dividing the voltage over the feedback resistor val...

Страница 51: ...0 320 0 125 0 080 0 250 0 160 Maxillary molar 0 320 0 200 0 500 0 400 0 160 0 100 0 320 0 200 Occlusal 0 250 0 160 0 500 0 320 0 125 0 080 0 250 0 160 Mandibular incisor 0 200 0 125 0 400 0 250 0 100...

Страница 52: ...9 Recommended exposure times 36 KaVo Dental GmbH 214760 rev 1...

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