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Focus

Buku Manual

2003 51706
Copyright Code: 51706-4AG Date: 09/2003

© 2003 by Instrumentarium Imaging

Documentation, trademark and the software are copyrighted with all rights
reserved. Under the copyright laws the documentation may not be copied,
photocopied, reproduced, translated, or reduced to any electronic medium or
machine readable form in whole or part, without the prior written permission
of Instrumentarium Imaging.

Focus complies with UL and C-UL (File E218408).

The original language of this manual is English.

Instrumentarium Imaging reserves the right to revise this publication from

time to time and to make changes in the content of it without obligation to
notify any person of such revision or changes.

Manufactured by Instrumentarium Imaging

P.O. Box 20
FIN-04301 Tuusula
FINLAND
Tel. +358 10 394 6500
Fax. +358 10 394 6501
E-mail: dental@fi.instrumentarium.com
Internet: http://www.InstrumentariumImaging.com
Table of Contents
1 Introduction ........................................................................................................ 1
1.1 General..................................................................................................................... 1
1.2 Markings and graphics symbols .............................................................................. 2
1.3 Type and version ..................................................................................................... 4
1.4 Labels on FOCUS.................................................................................................... 4
1.5 Configurations ......................................................................................................... 5
1.6 Radiation protection guidelines ............................................................................... 7
1.7 Manufacturer's liability............................................................................................ 8
1.8 Disposal ................................................................................................................... 9
2 Equipment controls .......................................................................................... 11
2.1 Main parts .............................................................................................................. 11
2.2 Symbols on remote control.................................................................................... 12
3 Preparations for the exposure ......................................................................... 15
3.1 Precautionary actions for safe use ......................................................................... 15
3.2 Switching the power on ......................................................................................... 15
3.3 Selecting the cone .................................................................................................. 15
3.4 Selecting the exposure parameters ........................................................................ 16
3.5 Positioning the patient ........................................................................................... 17
3.6 AEC Automatic Exposure Control ........................................................................ 18
3.7 Making an exposure............................................................................................... 18
4 Program mode................................................................................................... 21
5 Error messages.................................................................................................. 23
6 Maintenance ...................................................................................................... 25
6.1 Cleaning................................................................................................................. 25
6.2 Disinfecting ........................................................................................................... 25
6.3 Periodic maintenance............................................................................................. 26
7 Technical data ................................................................................................... 27
7.1 Technical specifications ........................................................................................ 27
8 User's statement................................................................................................ 31
9 Recommended digital/film exposure times..................................................... 37

51706-4AG Instrumentarium Imaging i

ii Instrumentarium Imaging 51706-4AG
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1 Introduction

1 Pendahuluan
1.1 Umum
FOCUS adalah alat intraoral x-ray dengan kontrol microprocessor dengan
generator Frekuensi tinggi DC. FOCUS menghasilkan gambar x-ray kualitas
tinggi pada film atau sensor.

Lengan yang seimbang mudah digerakkan dan sangat stabil, menjaga alat
tidak bergerak selama pemeriksaan berlangsung. Desain FOCUS' yang ek-
sklusif memiliki generator VHF DC di dalam bagian horizontal lengan alat
memungkinkan kehandalan dan kemudahan pemasangan.

Generator VHF DC menjaga dosisi radiasi minimum kepada pasien. Fitur-

fitur Remote kontrol yang mudah digunakan generator keeps the patient dose
to the absolute minimum. Fitur-fitur pada remote control yang mudah digu-
nakan, diprogram dengan anatomi tubuh membantu operator dalam memilih
jenis pemeriksaan dengan cepat. Pengaturan ini dapat diprogramkan sendiri
jika dierlukan.

Pilihan lain termasuk pilihan kV 60 atau 70 , waktu eksposi antara 0.02 dan
3.2 detik, model anak-anak atau dewasa, dan model film atau digital. Eksposi
dapat dilakukan langsung dari remote kontrol atau dengan tombol eksposi.
Dengan pilihan panjang lengan alat dan kemampuan mekanikal dalam konfigurasi
yang berbeda, FOCUS adalah sistem alat X-Ray yang dapat diandalkan.

Sebagai pabrik pembuat, kami merekomendasikan anda untuk membaca

buku manual ini sebelum melakukan service alat.

CATATAN
FOCUS harus diinstal berdasarkan manual instalasi FOCUS dan oleh teknisi.
Hanya teknisi yang terlatih yang dapat melakukan instalasi alat FOCUS.

51706-4AG Instrumentarium Imaging 1

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1 Introduction

1.2 Tanda dan simbol grafik

Tanda-tanda ini adalah yang digunakan dalam manual ini :

CATATAN
Mengandung informasi untuk pembaca tetang alat dan kegunaanya

PERHATIAN
Mengandung instruksi penting. Apabila instruksi tidak diperhatikan,
malfungsi atau kerusakan alat bisa terjadi.

PERINGATAN
MEngandung peringatan dan instruksi tentang keselamatan unit. Jika
peringatan ini diabaikan, resiko serius dan kecelakaan dapat terjadi kepada
pasien maupun operator.

2 Instrumentarium Imaging 51706-4AG

 1 Introduction

The following symbols are used in FOCUS

Focal spot

Total filtration

Radiographic control

Protective earth (ground)

Type B equipment

Dangerous voltage

ON (Power)

OFF (Power)

Attention, consult accompanying documents

If the unit has CE- marking it is CE- marked according to

the Medical Device Directive 93/42/EEC.

If the unit has UL-marking, it is UL-marked according to

UL 2601-1 and CAN/CSA C22.2 NO. 601.1.

X-ray source assembly: emitting

Radiation warning

51706-4AG Instrumentarium Imaging 3

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1. Pendahuluan
PPPeddPendahuluan
1.3 Type dan Versi
Tpe dan versi FOCUS tercantum pada lebel utama yang terpasang pada sisi
bagian bawah lengan horizontal alat, dan pada tabung / generator frekuensi
tinggi, label terdapat pada tabung. Alat kelas I, type B dan dengan proteksi
IP-20

Panjang focal tercantum pada label konus pada tambahan versi dan type.

Versi software sekilas telihat pada layar remote control setelah alat
dihidupkan.

1.4 Label pada Fokus

Type: Focus Made by This product complies with DHHS regulations

51703
Ser. No.: Instrumentarium Imaging 21 CFR Subchapter J applicable at date of manufacture.
Manufactured: P.O.Box 20, FIN-04301 TUUSULA, Finland Radiation area Ø 60 mm @ 30.5 cm (12 inch) SSD.

Type: Focus Made by This product complies with DHHS regulations

51712
Ser. No.: Instrumentarium Imaging 21 CFR Subchapter J applicable at date of manufacture.
Manufactured: P.O.Box 20, FIN-04301 TUUSULA, Finland Radiation area 35 x 45 mm @ 30.5 cm (12 inch) SSD.

Type: Focus Made by This product complies with DHHS regulations

51713
Ser. No.: Instrumentarium Imaging 21 CFR Subchapter J applicable at date of manufacture.
Manufactured: P.O.Box 20, FIN-04301 TUUSULA, Finland Radiation area 35 x 45 mm @ 22.9 cm (9 inch) SSD.

TUBE/HV GENERATOR
HOUSING ASSEMBLY
TYPE: Focus
Ser.No:
Tube type: D-0711 SB
Tube.No:
Date of manuf.:
0.7 mm
(IEC336:1993)
70 kV
maximum 840 mAs/h
Total Filtration:
2.0 mm Al 70kV
This product complies
with DHHS regulations 21
CFR Subchapter J at the
date of manufacture
FUSES/FUSIBLES Manufactured in Finland
230V~5 AT by Instrumentarium Corp.
115V~8 AT Imaging division
51700

P.O. Box 20, FIN-04301

WARNING: TUUSULA
For continued protection against risk of fire, replace
only with the same type and rating of fuses.

ATTENTION:
Pour assurer une protection
continue contre le risque d'incendie utilises
uniquement un fusible de rechange de meme !
51705

type et de memes caracteristiques nominales WARNING:

Voltages inside this cover can be deadly.
Peak voltage level normally exceeds 300V.

ATTENTION:
Les tensions à l'intèrieur peuvent être mortelles.
Tensions supèrieures à 300V.
51704

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1 Introduction

NOTE
Focus units are shipped with two types of main label depending on the fact if
the unit is UL-approved or not.

1.5 Konfigurasi
Focus dikirim dengan salah satu konfigurasi di bawah ini:

SYSTEM DASAR FOKUS, 50400:

Nomor Alat Penjelasan
50405 Alat x-ray FOCUS x-ray dengan
lengan pendek mencapai 176
cm/69.2", 115 V,
50406 Alat x-ray FOCUS lengan
panjang mencapai191 cm/75.1",
115 V
50409
Al at x-ray FOCUS dengan lengan
ekstra panjang mencapai 216 cm/
84.9", 115 V
50402 Alat x-ray FOCUS dengan
lengan pendek mencapai 176 cm/
69.2", 230 V
50403 Alat x-ray FOCUS dengan
lengan panjang mencapai 191
cm/75.1", 230 V
50404
Al at x-r ay FOCUS dengan lengan
panjang 216 cm/84.9", 230 V

Setiap system dasar Focus dilengkapi dengan remote contrl dengan panjang
kabel 32.8 kaki (10m) 8 kabel RJ-45.

51706-4AG Instrumentarium Imaging 5

1 Introduction

One chosen item from each module below is delivered with the basic unit:

TO BE CHOSEN FOR BASIC SYSTEM:

Part number Cones
50540 Short cone round
50550 Short cone rectangular
50410 Long cone round
50420 Long cone rectangular
50750 Short full metal rectangular cone
50720 Long full metal rectangular cone

Part number Wall mount plates

50440 Wall mount plate for single stud
50520 Wall mount plate for 16” center studs

Part number Manual language

50560 English user and installation manuals
50570 Italian user and installation manuals
50580 German user manual
50590 French user manual

Following accessories are approved items, and they can be ordered

separately.

ACCESSORIES
50540 Short cone round
50550 Short cone rectangular
50410 Long cone round
50420 Long cone rectangular
50720 Long full metal rectangular cone
50750 Short full metal rectangular cone
50500 Short horizontal arm 500 mm / 19.7 in
50510 Long horizontal arm 650 mm / 25.6 in
50450 Extra long horizontal arm 900 mm / 35.4 in

6 Instrumentarium Imaging 51706-4AG

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1 Introduction

50470 Additional remote control (two are possible to

be installed in one Focus unit)
50480 Remote exposure button (two are possible to be
installed in one Focus unit)
50440 Wall mount plate for single stud.
50520 Wall mount plate for 16" center studs.
50760 AEC Upgrade kit. For units from s/n F1482.
50770 AEC upgrade kit. For units with s/n up to
F1481.

NOTE
To maintain safe and correct operation of FOCUS, only the approved
accessories should be used. All the standard and optional items and approved
accessories are suitable for use within the patient environment.

1.6 Panduan Proteksi Radiasi

Alat ini menghasilkan radiasi sinar-x untuk tujuan medikal. Alat dapat saja
menyebabkan cidera apabila digunakan tidak sesuai. Instruksi tercantum
dalam manual harus dibaca dan diikuti saat mengoperasikan FOCUS. Semua
peraturan pemerintah dan lokal menyangkut proteksi radasi harus ditaati.

CATATAN
Untuk USA:
Banyak ketetapan dari peraturan-peraturan ini didasarkan pada rekomendasi
komite nasional untuk pengukuran dan proteksi radiasi. Rekomendasi untuk
proteksi x-ray dental tercatat pada laporan NCRP #35 tersedia dari publikasi
NCRP, 7910 Woodmont Avenue, Suite 1016, Bethesda, MD 20814.

Alat monitor personal dan proteksi tersedia dan direkomendasikan untuk

anggota staf. Ini juga direkomendasikan untuk menyediakan proteksi kepada
pasienyaitu apron. Konsultasikan terlebih dahulu sebelum melakukan pe-
meriksaan x-ray dental kepada pasien yang sedang hamil.

PERINGATAN
FOCUS tidak boleh digunakan dalam ruangan yang terdapat bahan peledak berbahaya.

Gunakan FOCUS dengan proteksi radiasi berdasarkan IEC 601-1-3:1994

(dan/atau keperluan lokal).

51706-4AG Instrumentarium Imaging 7

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1 Introduction

PROTECTION BY DISTANCE

In all examinations the user of the x-ray equipment should wear protective
clothing. The operator does not need to be close to the patient during normal
use. The protection against scatter radiation can be achieved by using the
remote control or the remote exposure button not less than 7 feet (2 meters)
from the focal spot and the x-ray beam. The cable length of the optional
remote exposure button is approximately 32 feet (10 meters). The operator
should maintain visible contact with the patient and technique factors. This
allows immediate termination of radiation by the release of the exposure
button in the event of a malfunction or disturbance.

WARNING:
This x-ray unit may be
dangerous to patient and
operator unless safe
exposure factors and
operating instructions
are observed.

Table 1.1 Caution information on remote control

1.7 Tanggung jawab Produsen

Sebagai produsen kami hanya dapat bertanggung jawab atas keselamatan dan
kehandalan pengoperasian alat ini apabila :

• Instalasi FOCUS dilakukan berdasarkan manual instalasi

• FOCUS digunakan berdasarkan manual penggunaan bagi pengguna
• Perawatan dan perbaikan dilakukan oleh dealer resmi
• Suku cadang yang digunakan adalah asli atau yang direkomendasikan

Jika service dilakukan pada alat, harus ada penjelasan dari permintaan service
untuk jenis tindakan yang dilakukan dan apabila ada tindakan perbaikan harus
dilakukan oleh teknisi resmi. Harus termasuk informasi penggantian atau jum-
lah tindakan yang sudah dilakukan. Permintaan kerja selanjutnya harus men-
cantum tanggal perbaikan, nama perusahaan dan tanda tangan resmi. Penggu-
na harus menyimpan permintaan kerja ini untuk referensi dikemudian hari.

8 Instrumentarium Imaging 51706-4AG

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1 Introduction

1.8 Pembuangan limbah

Saat alat tidak lagi memenuhi spesifikasi operasional pabrik,meskipun sudah
diperbaiki, maka alat harus diganti. Ikuti semua peraturan pembuangan
limbah. Fokus memiliki bagian sebagai berikut yang harus dianggap sebagai
limbah tidak ramah lingkungan antara lain :

- Rangkaian sumber X-ray

- Semua rangkaian listrik

51706-4AG Instrumentarium Imaging 9

1 Introduction

10 Instrumentarium Imaging 51706-4AG

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controls

2 Kontorol Peralatan
2.1 Bagian utama

51706-4AG Instrumentarium Imaging 11

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2 Equipment controls

2.2 Simbol pada remote control

Molar maxillary (Rahang atas)

Insisivus maxillary/bicuspid

Kaninus Maxillary

Bitewing

Molar Mandibula (rahang bawah)

Insisivus Mandibula/bicuspid

Kaninus Mandibula

Occlusal

Tombol penyinaran

Sumber x-ray: penyinaran

Peringatan radiasi

Mode anak dan dewasa

Mode film digital

Pilihan tegangan, 60 or 70 kV

Perhatian, Dokumen konsultasi terlampir

Peringatan radiasi

Tampilan waktu penyinaran

12 Instrumentarium Imaging 51706-4AG

 2 Equipment controls

Exposure time control

AEC (Automatic Exposure Control)

51706-4AG Instrumentarium Imaging 13

2 Equipment controls

14 Instrumentarium Imaging 51706-4AG

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exposure

3 Persiapan untuk penyinaran

3.1 Tindakan pencegahan untuk keselamatan penggunaan
Periksa bahwa sisi alat memungkinkan FOCUS untuk diaturthe site of the
unit allow pada semua posisi tanpa menabrak benda lain.

PERINGATAN
Grounding yang sesuai tidak dapat dipastikan sampai FOCUS terhubung
pada kabel stop kontak ruhamah sakit yang sesuai.

3.2 Menghidupkan alat

Tombol power terletak pada bagian bawah blok akses. Tekan tombol power
pada posisi ON . Lampu indikator hijau akan menyala. Alat akan melakukan
pemanasan sendiri.

Layar display akan menyala dan membaca waktu penyinaran terakhir digu-
nakan. Juga lampu indikator akan menyala menunjukkan nilai faktor eksposi
sebelumnya untuk jenis gigi, ukuran pasien, mode film/digital dan pilihan
kV.

Lampu indikator hijau akan menyala apabila penyinaran dapat dilakukan

The green READY light will illuminate when an exposure can be made.
PERINGATAN
Matikan alat apabila terjadi error atau pengoperasian yang salah.

3.3 Pilih Konus

Pilihan konus termasuk konus berbentuk bundar atau segiempat panjang
atau pendek.

Jika konus dengan panjang berbeda dari yang ditetapkan dari pabrik, masuk
ke mode program dan pilih panjang konus yang diinginkan seperti dijelaskan
pada bagian“ Program Mode” pada manual ini. lepaskan konus dengan cara
putar dan tarik keluar. Kemudian dorong dan putar konus yang baru. RINN,
atau jenis lain dari holder film/sensor dapat digunakan untuk konus-konus
ini.

51706-4AG Instrumentarium Imaging 15

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3 Preparations for the exposure

NOTE
Make sure that the values set in the programming mode correspond to the
cone length.

3.4 Memilih parameter ekspose

1 Tekan tombol kV untuk berpindah pada pilihan 60 kV atau 70 kV.
Lampu indikator akan menandai pilihan yang dipilih.
2 Tekan tombol ukuran pasien untuk berpindah pada pilihan anak dan de-
wasa. Lampu indikator yang berdekatan akan mengidikasikan pilihan
yang dipilih
3. Tekan tombol D untuk memilih mode Film atau Digital. Lampu akan
333333
menyala pada mode Digital
3
..
3 PERHATIAN
Pastikan mode alat pengambilan gambar pada posisi On (Film/Digital) .

4 Tekan salah satu tombol yang menunjukkan waktu eksposi untuk 8

anatomi gigi (tombol gigi). Lampu indikator yang berdekatan akan
menyala untuk mengindikasikan pilihan. Lampu indikator gigi yang
lain akan mati

16 Instrumentarium Imaging 51706-4AG

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exposure

5 Waktu penyinaran dapat diatur secara manual dengan tombol Up dan

Down. Waktu eksposi didasarkan pada tipe gigi, ukuran pasien, mode
eksposi (Film/Digital), nilai kV, kecepatan film dan panjang konus.
Waktu penyinaran akan terlihat pada layar display dengan model dua
desimal. Kapanpun parameter yang ditentukan diubah, waktu penyi-
naran akan berubah dan muncul pada layar.
6 Tutup pintu apabila tombol pintu dipasang.

3.5 Posisikan pasien

1 Atur kepala pasien pada posisi benar berdasarkan pilihan mode
pemeriksaan.
2 Tempatkan film/sensor kedalam mulut pasien. Posisikan konus
mengarah ke pasien dengan arah sinar tegak lurus terhadap film/sensor
dan perhatikan posisi penyudutan arah sinar. Skala penyudutan terdapat
pada bagian sambungan lengan dengan tabung.

Maxillary anterior Maxillary molar Mandibular anterior

Mandibular canine Mandibular molar Mandibular occlusal

Maxillary occlusal Bite-wing

3 Gunakan jarak sejauh mungkin untuk mengurangi dosis serendah

mungkin namun dapat memberikan informasi klinis yang diperlukan
4 Instruksikan pasien untuk tidak bergerak selama penyinaran berlangsung

51706-4AG Instrumentarium Imaging 17

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3 Persiapan untuk penyinaran

PERHATIAN
Awas jangan sampai pasien terbentur dengan alat pada saat memposisikan pasien

3.6 AEC Automatic Exposure Control

Fungsi AEC adalah untuk mengontrol dosis secara otomatis. Fitur ini hanya
dapat digunakan dengan intra oral sensor sigma dari Instrumentarium
imaging. Fungsi AEC dicapai dengan penggantian data melalui komunikasi
digital FocusLink antara Sigma dan Focus.Komunikasi memungkinakn wak-
tu penyinaran, kV, mA, dipindahkan secara otomatis dari Focus ke software
aplikasi pengguna pada mode manual dan otomatis. FocusLink adalah suatu
bagian terpisah dari list aksesoris Sigma (lihat manual Sigma)

AEC dikontrol dari kontrol panel Focus. Operasi dari sigma atau software
aplikasi tidak diubah. AEC berfungsi hanya bila Sigma sudah teroneksi den-
gan Focus dan Focus dapat dioperasikan. Saat AEC dipilih pada Focus, Sig-
ma mengubah operasi internalnya ke fungsi AEC.

AEC dapat aktifkan atau dinonaktifkan dengan tombol AEC, yang selalu
menghidupkan mode digital sekalipun mode digital sudah on. Tidak memilih
mode Digital akan juga menonaktifkan mode AEC. Saat AEC dipilih, display
remote kontrol tidak akan aktif. Namun, setelah eksposi, waktu penyinaran
akan muncul pada display.

3.7 Melakukan eksposi/penyinaran

Ada beberapa hal yang perlu diperhatikan sebelum melakukan eksposi antara lain :

• Tabung sinar-x tidak boleh terlalu panas

• Harus ada energi yang cukup pada tabung sinar-x
• Unit harus berada dalam posisi siap dioperasikan (tidak dalam program mode service)

1 Apabila semua hal diatas terpenuhi, maka lampu indikator hijau

akan menyala pada panel kontrol
2 Gunakan tomo either the handheld/wall external exposure switch or
the exposure button on the remote control.
3 Press and hold the exposure button through the entire exposure cycle
until the audible signal terminates.

NOTE
In the AEC mode the time of pressing is a little longer than in the manual
mode.

During the exposure, the yellow warning light will illuminate and the beeper
will be activated. These two actions will stop when the exposure is completed
or if the exposure button is released prematurely. The exposure time display
will go blank during the exposure and will reflect the elapsed time of the
actual exposure afterwards.

18 Instrumentarium Imaging 51706-4AG

 3 Preparations for the exposure

NOTE
When using the system in an extremely high electromagnetic environment
interferences may change image quality. If interference appears, contact your
FOCUS dealer.

51706-4AG Instrumentarium Imaging 19

3 Preparations for the exposure

20 Instrumentarium Imaging 51706-4AG

 4 Program mode

4 Program mode
Enter or exit the program by pressing and holding the kV button for two
seconds or more. The beeper will sound three times. No exposures may be
taken while in the program mode. The READY light will be off.

The menu selections are scrolled with the UP and DOWN buttons. Enter or
exit the selection by pressing the kV button. Data is edited with the UP
button.

The program mode will exit automatically after it remains idle for 30
seconds. When control returns to the operating 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 Length Pr2
short cone SC
long cone LC
Exposure Counter Pr3
First (1000 - 99000) 2 digits displayed
Second (0 - 999) 3 digits displayed
AEC default Pr4
AEC ON by default AEC
AEC OFF by default ---
Set Factory Defaults, two beeps Pr5

PROGRAMMABLE ANATOMICAL TIME SETTINGS

The anatomical time settings (tooth buttons) have been preprogrammed by

the factory but can be changed if necessary by the user. This is done similarly
to programming the preset buttons on a car radio. First increase or decrease
the exposure time with UP and DOWN buttons. Then press and hold the
corresponding tooth button for two seconds or more. The beeper will beep
two times. The new time setting is now saved into the memory.

51706-4AG Instrumentarium Imaging 21

4 Program mode

22 Instrumentarium Imaging 51706-4AG

 5 Error messages

5 Error messages
The error messages are grouped into two categories. User errors (H) and
system fault errors (E). User errors must either be acknowledged or it will be
removed once the error is corrected. When system faults occur, a service
technician should be contacted.

Display Contents Error or Failure Action

E1 KV failure Contact the service

E2 MA failure Contact the service
E3 PREH failure Contact the service
E4 Tube head too hot or Wait for valid tube
too cold head temperature
E5 Line voltage low Contact the service
E6 Sigma link error or Contact the service
sensor not ready
E7 EEPROM failure Contact the service
necessary waiting time Duty cycle Wait for tube to cool
H2(flashes alternately Premature button Acknowledge with UP
with elapsed exposure release or DOWN button
time)
H3 Door open (from Check that door is
Adjustment part) closed
H4 Door open (from Check that door is
Remote) closed
H5 System in Service Go to the user mode
mode
H6 Current Sigma Change resolution
clocking mode and mode to minimum
resolution selection do dose in CliniView.
not support AEC. This error message
may appear only with
CliniView 3.0 or
earlier
H7 Exposure out of range, Too much attenuation
exposure cancelled (in between the sensor
AEC mode) and the tube. Check
that the tubehead and
the sensor are
correctly aligned.

51706-4AG Instrumentarium Imaging 23

5 Error messages

24 Instrumentarium Imaging 51706-4AG

 6 Maintenance

6 Maintenance
6.1 Cleaning
The cone should be cleaned or re-draped after every patient usage. Items and
surfaces that are not given special instructions for cleaning, disinfecting and
sterilizing, can be cleaned with a soft cloth moistened with disinfectant after
each usage.

WARNING
Always disconnect focus from the power supply or switch off the power prior
to cleaning or disinfecting the unit. Do not allow any liquid to enter the unit
interior.

CAUTION
Do not allow water or other cleaning liquids to enter the unit interior since
these may cause damage.

Use a cloth moistened in cool-to-lukewarm, soapy water to clean the unit, and
prevent 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 uncertain of the nature of
cleaning agent, do not use it.

For example, the following cleaning agents are allowed (and not allowed) to
clean the unit panels:

Allowed:

Soap, Butylalcohol, Ethanol (ethyl alcohol) 96%, Methanol (methyl alcohol).

Not allowed:

Benzene, all chlorine solutions, Phenol, Acetone, Acetic ether

6.2 Disinfecting
Use Ethanol 96% for disinfecting of equipment. Wipe manually with clean
cloth moisturized in disinfectant solution. Never use corrosive or solvent
disinfectants. All items and surfaces should be dried before next usage.

NOTE
Wear gloves and other protective gear during disinfecting process.

WARNING
Do not use any disinfecting sprays since the vapor could ignite causing injury.

51706-4AG Instrumentarium Imaging 25

6 Maintenance

Disinfecting techniques for both the unit and the room must comply with all
laws and regulations that have jurisdiction within which the unit is located.

6.3 Periodic maintenance

This unit is designed to provide reliable performance and many years of
customer satisfaction. In order to assure safe performance, the unit must be
checked by a qualified service technician. It is the owner's responsibility to
supply or arrange for this service. Consult your Focus dealer for such service.
In addition to periodic maintenance any deviation from normal performance
should be immediately reported to your dealer.

WARNING
Only trained and qualified personnel should be permitted access to the
internal parts of the focus unit.

CAUTION
After the operation in the service mode the unit must be switched off.

The user should perform the following inspections on a monthly basis:

– Visually check that all visible labels are intact and legible
– Visually check that the exposure indicator light illuminates for the
duration of exposure
– Confirm that the audible indicator beeps for the duration of the
exposure
– Check that exposure button must be kept pressed continuously during
the exposure cycle
– Check that exposure terminates when the exposure button is
prematurely released
– Check all the functions of the remote control.

26 Instrumentarium Imaging 51706-4AG

 7 Technical data

7 Technical data
7.1 Technical specifications

MANUFACTURER: Instrumentarium Corp., Imaging

Division P.O. Box 20, FIN-04301
Tuusula, FINLAND
MANUFACTURER’S QUALITY In accordance with ISO 9001
SYSTEM: standard
ENVIRONMENTAL In accordance with ISO 14001
MANAGEMENT SYSTEM: standard
ELECTRICAL & MECHANICAL According to IEC 60601-1,CE
SAFETY: models marked according to the
Medical Device Directive 93/42/
EEC

PRODUCT NAME FOCUS

TYPE Intraoral x-ray unit

UNIT DATA

Class I
Type B
Protection IP-20
Operation Continuous operation with
intermittent loading
Software version 1.0

X-RAY GENERATOR

Generator type Constant potential

Nominal power 800 W
High voltage DC
Supply frequency 100-200 kHz
Number of phases 1
Reference current time product 7 mAs (70 kV, 7 mA, 1 s)
Lowest current time product 0.14 mAs (70 kV, 7mA, 0.02 s)

51706-4AG Instrumentarium Imaging 27

7 Technical data

TUBE HEAD ASSEMBLY

Tube head assembly type THA-I

Tube type Toshiba D-0711SB or D-0711S
Max. tube voltage 60-70 kV
Max. tube current 7 mA
Max. electric output 490 W (70kV; 7mA; 0.1s)
Reference axis Runs axially with the cone
Target angle 16 degrees
Focal spot 0.7 mm (IEC 60336)
Nominal anode input power 940 W
Max. symmetrical radiation field ∅60 mm at a 200 mm focal length
Total filtration 2 mm Al (70 kV)
Inherent filtration 2 mm Al (70 kV)
Additional filtration 0 mm Al (70 kV)
Max. anode heat content 7 kJ
Maximum X-ray tube assembly 140 kJ
heat content
Maximum continuous heat 19 W
dissipation of the X-ray tube head
assembly

ELECTRICAL CONNECTIONS

Nominal mains voltage 115 VAC +/- 10%

230 VAC +/- 10%
Input power frequency 60 Hz
50 Hz
Nominal current 8A
5A
Mains fuse, slow blow 8 A / 115 VAC 5 A / 230 VAC
Internal fuse 1.6 A / 115 VAC 1 A / 230 VAC
Apparent resistance of supply 0.68Ω
mains
Power consumption 1240 VA / 230 VAC
1040 VA / 115 VAC
Main voltage selection X45 / 230 V
X46 / 115 V

28 Instrumentarium Imaging 51706-4AG

 7 Technical data

ELECTRICAL CONNECTIONS

US/Canada mains connector type 115 V / NEMA 6-15P or similar

Power supply cords type H05VV5-F / AWG 14 (UL 2587)

WARNING
Proper grounding cannot be ensured unless FOCUS is connected to properly
wired hospital grade outlet.

EXPOSURE TIME RANGE 0.02 - 3.2 s

EXPOSURE TIME RANGE IN AEC MODE 0,02- 1,6 s

BEAM LIMITING DEVICE

Cone dimensions Round: ∅ 60 mm

Rectangular: 35 x 45 mm

PHYSICAL MEASURES AND AMBIENT TEMPERATURES:

Focal length (Standard/Long) 9 inches (229 mm) / 12 inches (305

Installation
Height x Width x Depth (mm)
Weight
Type and length of the cable of the
remote exposure switch
Transportation and Storage
Operation Temperature
mm)
Standard wall mount Optional base
for free standing unit
Unit: 1037 mm, 129 mm, 971 mm /
2170mm Tube head assembly: 112
mm, 231 mm, 201 mm
Unit: approximately 66 pounds (30
kg) Tube head assembly:
approximately 10 pounds (4.5 kg)
Length approximately 32.5 feet (10
m), RJ-45 plug at both ends (8
wires)
-40F...+158F (-40°...+70°C), RH
10...100%
+50F...+104F (+10°...+40°C), RH
max. 70%

51706-4AG Instrumentarium Imaging 29

7 Technical data

30 Instrumentarium Imaging 51706-4AG

 8 User's statement

8 User's statement
Instructions for the use of the FOCUS and precautionary statements are part
of the FOCUS User's Manual.

RADIATION LEAKAGE TECHNIQUE FACTORS

The maximum-rated peak tube potential is 70 kVp with the maximum rated
continuous tube current of 1.5 mA.

BEAM LIMITING DEVICE / TUBE HOUSING ASSEMBLY

COMPATIBILITY

The tube housing assembly THA-I is compatible with the beam limiting
device.

Part number Cones

50540 Short cone round
50550 Short cone rectangular
50410 Long cone round
50420 Long cone rectangular
50750 Short full metal rectangular cone
50720 Long full metal rectangular cone

EQUIPMENT STATEMENT FOR TUBE HOUSING ASSEMBLY

Maximum operating voltage is 70 kVp. Nominal focal spot is 0.7 mm.

X-ray tube: Toshiba D-0711SB or D-0711S. For additional information

please refer to the tube specification sheets.

MAXIMUM DEVIATION FROM INDICATED VALUES

PARAMETER INDICATED DEVIATION

VALUE

Tube voltage 60 - 70 kVp ± 1.3 kVp

Tube current 7 mA ± 1mA or 15%,
whichever is larger
Exposure time 0.02 - 3.2 s ± (10% + 1ms)

POWER SUPPLY REQUIREMENTS

Rated nominal voltage 115 / 230 VAC, 60 / 50 Hz single phase. Line voltage
range is 115 ± 10% and 230 ±10% VAC. Automatic regulation for all
voltages within the line voltage range.

51706-4AG Instrumentarium Imaging 31

8 User's statement

MAXIMUM LINE CURRENT

With 115 VAC power supply systems the maximum line current during the
exposure is 8 A, at stand by maximum 0.2 A. The system line fuses are 8 A
slow blow type.

With 230 VAC power supply systems the maximum line current during the
exposure is 5 A, at stand by maximum 0.1 A. The system line fuses are 5 A
slow blow type.

TUBE RATINGS, TUBE HEAD COOLING CURVE

Fig 8.1. Maximum Rating Chart (D-0711SB or D-0711S)

32 Instrumentarium Imaging 51706-4AG

 8 User's statement

Fig 8.2. Tube anode thermal characteristics (D-0711SB or D-0711S)

TUBE HEAD THERMAL CHARACTERISTICS

Fig 8.3. Tube head assembly cooling curve

51706-4AG Instrumentarium Imaging 33

8 User's statement

WAIT TIMES BETWEEN EXPOSURES

Below are the wait times for different exposures.

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 19s
0.06s 10s 0.80s 24s
0.08s 10s 1.00s 30s
0.10s 10s 1.25s 50s
0.12s 10s 1.60s 64s
0.16s 10s 2.00s 80s
0.20s 10s 2.50s 100s
0.25s 10s 3.20s 128s

DIMENSIONAL OUTLINE OF THE TUBEHEAD

Fig 8.4. Tubehead dimensions and the location of the focal spot

NOTE
Wiring diagrams, schematics, and other documents which are needed for
repairing the unit, will be supplied by Instrumentarium Imaging on request.

34 Instrumentarium Imaging 51706-4AG

 8 User's statement

MEASUREMENT CRITERIA FOR EXPOSURE TIME

Exposure time

Exposure time consists of beginning and ending points as measured by a

calibrated x-ray monitor at 70% of the peak radiation waveform

kV

The high voltage mean value received after measurement with a calibrated x-
ray monitor

mAs

The resistance value divided by voltage. A calibrated x-ray monitor measures

the voltage over feedback resistor and provides a mAs value.

The nominal x-ray voltage 70kV is obtained at highest tube current 7mA.

The nominal tube current 7mA is obtained at the highest tube voltage
70kV.

The highest electric power is obtained at 70 kV tube voltage and 7 mA

tube current.

The nominal electric power of 490 W is obtained when loading time is 0.1s
and nominal x-ray tube voltage 70 kV is used.

Instrumentarium Imaging reserves the right to make technical changes at any

time.

51706-4AG Instrumentarium Imaging 35

8 User's statement

36 Instrumentarium Imaging 51706-4AG

 9 Recommended digital/film exposure times

9 Recommended digital/film exposure times

70 kV (9” Adult Child

cone)
Tooth Area / Dig. D E F Dig. D E F
Media
Maxillary 0.02 0.2 0.1 0.08 0.025* 0.125* 0.063* 0.05
Incisor
Maxillary 0.02 0.25 0.125* 0.1 0.025* 0.16 0.08 0.063*
Cuspid
Maxillary 0.032* 0.32 0.16 0.125* 0.02 0.2 0.1 0.08
Molar
Occlusal 0.04 0.4 0.2 0.16 0.025* 0.25 0.125* 0.1
Mandibular 0.02 0.16 0.08 0.063* 0.02 0.1 0.05 0.04
Incisor
Mandibular 0.02 0.2 0.1 0.08 0.02 0.125* 0.063* 0.05
Cuspid
Mandibular 0.025* 0.25 0.125* 0.1 0.02 0.16 0.08 0.063*
Molar
Bitewing 0.04 0.4 0.2 0.16 0.025* 0.25 0.125* 0.1

60 kV (9" Adult Child

cone)
Tooth Area / Dig. D E F Dig. D E F
Media
Maxillary 0.04 0.4 0.2 0.16 0.025* 0.25 0.125* 0.1
Incisor
Maxillary 0.05 0.5 0.25 0.2 0.032* 0.32 0.16 0.125*
Cuspid
Maxillary 0.063* 0.63 0.32 0.25 0.04 0.4 0.2 0.16
Molar
Occlusal 0.08 0.8 0.4 0.32 0.05 0.5 0.25 0.2
Mandibular 0.032* 0.32 0.16 0.125* 0.02 0.2 0.1 0.08
Incisor
Mandibular 0.04 0.4 0.2 0.16 0.025* 0.25 0.125* 0.1
Cuspid
Mandibular 0.05 0.5 0.25 0.2 0.032* 0.32 0.16 0.125*
Molar
Bitewing 0.08 0.8 0.4 0.32 0.05 0.5 0.25 0.2

51706-4AG Instrumentarium Imaging 37

9 Recommended digital/film exposure times

70 kV (12" Adult Child

cone)
Tooth Area / Dig. D E F Dig. D E F
Media
Maxillary 0.04 0.4 0.2 0.16 0.025* 0.25 0.125* 0.1
Incisor
Maxillary 0.05 0.5 0.25 0.2 0.032* 0.32 0.16 0.125*
Cuspid
Maxillary 0.063* 0.63 0.32 0.25 0.04 0.4 0.2 0.16
Molar
Occlusal 0.08 0.8 0.4 0.32 0.05 0.5 0.25 0.2
Mandibular 0.032* 0.32 0.16 0.125* 0.02 0.2 0.1 0.08
Incisor
Mandibular 0.04 0.4 0.2 0.16 0.025 0.25 0.125* 0.1
Cuspid
Mandibular 0.05 0.5 0.25 0.2 0.032* 0.32 0.16 0.125*
Molar
Bitewing 0.08 0.8 0.4 0.32 0.05 0.5 0.25 0.2

60 kV (12" Adult Child

cone)
Tooth Area / Dig. D E F Dig. D E F
Media
Maxillary 0.08 0.8 0.4 0.32 0.05 0.5 0.25 0.2
Incisor
Maxillary 0.1 1.0 0.5 0.4 0.063* 0.63 0.32 0.025*
Cuspid
Maxillary 0.125* 1.25 0.63 0.5 0.08 0.8 0.4 0.32
Molar
Occlusal 0.16 1.6 0.8 0.64 0.10 1.0 0.5 0.4
Mandibular 0.063* 0.63 0.32 0.25 0.04 0.4 0.2 0.16
Incisor
Mandibular 0.08 0. 0.4 0.32 0.05 0.5 0.25 0.2
Cuspid
Mandibular 0.1 1.0 0.5 0.4 0.063* 0.63 0.32 0.25
Molar
Bitewing 0.16 1.68 0.8 0.64 0.10 1.0 0.5 0.4

* The third decimal place is not shown on the display

Dig. = Digital sensors

D = Speed D

E = Speed E

F = Speed F

38 Instrumentarium Imaging 51706-4AG


Instrumentarium Imaging
P.O.Box 20, FIN-04301 Tuusula, Finland
Tel. +358 10 394 6500 · Fax +358 10 394 6501
dental@fi.instrumentarium.com
Instrumentarium Imaging Inc.
300 West Edgerton Avenue, Milwaukee
Wisconsin 53207, USA
Tel. +1 800 558 6120, +1 414 747 1030
Fax +1 414 481 8665
info@usa.instrumentarium.com
Instrumentarium Imaging France S.A.R.L.
4, Avenue des Roses
94386 Bonneuil Sur Marne Cedex, France
Tel. +33 1 43 39 51 51 · Fax +33 1 43 39 75 75
instrumentarium.imaging@wanadoo.fr
Instrumentarium Imaging Italia S.R.L.
Via Cassanese, 100
20090 Segrate (MI), Italy
Tel. +39 02 21 30 28 1 · Fax +39 02 21 30 28 60
instrumentarium@it.instrumentarium.com
51706 2003 © Instrumentarium Imaging
Instrumentarium Imaging Singapore
152 Beach Road
#12-03A Gateway East
189721 Singapore
Tel. +65 6391 8600 · Fax +65 6396 3009
singapore@sg.instrumentarium.com
Instrumentarium Imaging Dental GmbH
P.O.Box 2044, 77680 Kehl am Rhein, Germany
Tel. +49 7851 932 90 · Fax +49 7851 932 930
kontakt@instrumentarium-imaging.de

Instrumentarium Imaging is constantly improving its products and reserves the right to
change these specifications without notice. Distributor:

www.InstrumentariumImaging.com