ARDET ORIX HF VET User manual

ORIX HF VET :
User manual

ORIX HF VET : User manual
V. 1.02 May 2016
2

ORIX HF VET : User manual
V.1.02 May 2016
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0051
Ardet Dental Medical Devices S.r.l.
Via Galvani, 15
20090 Assago (Milan) Italy
Phone: [phone]
Fax [phone]
E-mail: [e-mail]
Web Site:www.ardetsrl.com
Orix HF Vet High Frequency Dental X-ray System
User Manual – English Edition
Version 1.02 May 2016
Ardet Dental & Medical Devices S.r.l. is committed to total quality.
Thank you or noti ying us any error ound in this document

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Table o Contents
1 General Information .................................................................................................................................. 6
1.1 Congratulations .................................................................................................................................. 6
1.2 Purpose .............................................................................................................................................. 6
1.3 Equipment Classification ................................................................................................................... 6
1.4 Explanation of symbols on technical labels....................................................................................... 7
1.5 Product Description ........................................................................................................................... 8
1.6 Safety recommendations.................................................................................................................... 9
2 Technical description ............................................................................................................................... 13
2.1 Alimentation .................................................................................................................................... 13
2.2 Operating, transport and storage conditions .................................................................................... 14
2.2.1 Transport and storage conditions ............................................................................................. 14
2.2.2 Operating condition ................................................................................................................. 14
2.3 Rating charts .................................................................................................................................... 15
3 Controls and functional elements ............................................................................................................ 17
3.1 Operating and Display Elements ..................................................................................................... 17
3.2 Meaning of the icons ....................................................................................................................... 18
3.3 Exposure times ................................................................................................................................ 19
3.3.1 Possible exposure times in seconds ......................................................................................... 19
3.3.2 Pre-programmed exposure times for films of sensitivity class D (FILMD) ............................ 19
3.3.3 Pre-programmed exposure times for films of sensitivity class E (FILME) ............................. 20
3.3.4 Pre-programmed exposure times for films of sensitivity class F (FILMF) ............................. 20
3.3.5 Pre-programmed exposure times for digital sensors (RVG.1) ................................................ 21
3.3.6 Pre-programmed exposure times for phosphor plates(PSP.1) ................................................. 21
4 Use ........................................................................................................................................................... 22
4.1 Preparing the exposure .................................................................................................................... 22
4.1.1 Switch the unit on .................................................................................................................... 22
4.1.2 Setting Parameters ................................................................................................................... 23
4.1.3 Manually changing the exposure time ..................................................................................... 23
4.1.4 Change the level of high voltage ............................................................................................. 24
4.2 Positioning the patient/X-ray tube assembly ................................................................................... 24
4.3 Releasing the exposure .................................................................................................................... 25
4.4 Canceling an exposure ..................................................................................................................... 25
4.5 Pause/cooling down ......................................................................................................................... 26
5 Maintenance ............................................................................................................................................ 27
5.1 Cleaning and care ............................................................................................................................ 27
5.1.1 Cleaning ................................................................................................................................... 27
5.1.2 Disinfecting ............................................................................................................................. 27

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5.2 Inspection and maintenance ............................................................................................................. 28
6 Error messages ......................................................................................................................................... 29
6.1 List of error messages ...................................................................................................................... 29
7 Disposal ................................................................................................................................................... 30
7.1 Disposal of the X-ray tube assembly ............................................................................................... 30
8 Compliance with applicable standards .................................................................................................... 31
8.1 Electromagnetic Compatibility ........................................................................................................ 32
8.1.1 Electromagnetic emissions ...................................................................................................... 32
8.1.2 Interference immunity ............................................................................................................. 33
8.2 Identifiation labels ........................................................................................................................... 37
8.2.1 Stand mobile unit labels .......................................................................................................... 37
8.2.2 Wall mount unit lables ............................................................................................................. 38
8.3 Contact Information ......................................................................................................................... 38
8.3.1 Customer Service ..................................................................................................................... 38
8.3.2 Manufacturer's address ............................................................................................................ 38

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1 General In ormation
1.1 Congratulations
Dear Customer,
Thank you for purchasing the high frequency dental X-ray system ORIX HF VET, a state of the art
equipment which will assist in your profession day after day performing consistently for many years.
The unit is manufactured under a quality control system which grants full compliance to specifications.
To safeguard your warranty claims, please complete the " Warranty certificate" together with the service
engineer immediately after the installation of your unit.
1.2 Purpose
ORIX HF VET is an intraoral X-ray system. It is intended for use in dental radiographic examination and
diagnosis of diseases and disorders of the teeth, the jaw and oral structures.
The system can be configured for wall, stand fixed or stand mobile solutions.
The available features make the use simple and grant long life with minimum maintenance requirements.
The User Manual and the Service Installation Manual supplied with the system are also part of the
product. Always keep this documentation within easy reach.
Please familiarize yourself with the unit by reading through these operating instructions before taking any X-
rays of patients. Please comply with the applicable radiation protection regulations and warnings at all times.
ARDET recommends regular constancy tests to ensure image quality.
1.3 Equipment Classi ication
ORIX HF is:
- an EN Class I, type B equipment (EN 60601-1)
- a Class II b medical device equipment (MDD 93-42 CE / 2007-47 CE)
Copyright
Documentation for Ardet ORIX HF VET and the operating software are copyrighted with all rights reserved. Under the copyright laws, this
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 Ardet Dental Medical Devicese S.r.l.

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1.4 Explanation o symbols on technical labels
Type of protection against direct and indirect contacts: class II Degree of protection
against direct and indirect contacts: unit with applied part type B.
Consult written instructions in User’s Manual
Warning X-ray
X-ray emission
L
Line Point (for equipment permanently connected to line)
N
Neutral Point (for equipment permanently connected to line)
Protective Earth
Electronic equipment – Do not recycle in normal trash

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1.5 Product Description
ORIX HF VET system consists of six components, as shown in the Component Diagram
1) Control Unit The control unit provides for the input power connection and control of the
Tubehead and Operator Panel. It provides kVp and exposure time control.
The Control Unit consists of the mounting base and Operator Panel.
2) Tubehead The Tubehead contains the x-ray tube, high voltage circuit, and Cone
3) Double Counterbalanced Arm The double counterbalanced arm provides the articulation support
for the tubehead and the reach and coverage of the tubehead to the patient. The double
counterbalanced arm allows smooth movement for precise positioning and does not drift or vibrate
when left in position
4) Horizontal Arm The horizontal arm helps provide the necessary reach for the ORIX HF VET. The
Horizontal Arm pivots smoothly around a shaft inserted in the top of the Wall Plate. The Horizontal
Arm contains an access cover to connect the cable from the Horizontal Arm to the Control Unit. The
Horizontal Arm is available in two lengths, providing two different reaches.
5) Cone The Cone establishes the distance from the x-ray tube to the patient’s skin. It provides
positioning assistance and collimates the x-ray beam to within a defined circle at its end. ORIX HF
VET tubehead has already a standard 8 inch cone installed.
6) Wall Plate. The wall plate allows the unit can be supported

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CAUTION
Do not hang lead aprons on the horizontal extension arm.
Optional
Mobile Unit are optional device, the mobile unit supports pre-programmed technique selections and x-ray
acquisition.
Installation and Service
The ORIX HF VET Dental X-Ray System should only be installed and serviced by approved ARDET.
Dental Medical Devices S.r.l. dealer personnel. Contact ARDET at [phone] if you need
assistance locating an approved dealer.
1.6 Sa ety recommendations
Identi ication o danger levels
To prevent personal injury and material damage, please observe the warning and safety information provided
in this document. Such information is highlighted as follows:
WARNING
Warning o bodily injury
A possibly dangerous situation that could result in serious bodily injury or death.
CAUTION
Caution against damage
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
In ormation to make work easier
Si riferisce alle indicazioni sull’utilizzo e ad altre informazioni utili.
Intended use
This equipment must not be used in the presence of flammable or potentially explosive gases or vapors,
which could ignite, causing personal injury and/or damage to the equipment. If such disinfectants are used,
the vapor must be allowed to disperse before using the equipment.

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ORIX HF VET is an intraoral X-ray system which intended use is the dental X-ray examination and
diagnose of diseases of the teeth, jaw, and structures of the mouth.
ORIX HF VET Dental X-Ray System is an ordinary type medical equipment without protection against
ingress of liquids. To protect against short-circuit and corrosion, no water or any other liquid should be
allowed to leak inside the equipment.
This equipment must only be used in rooms or areas that comply with all applicable laws and
recommendations concerning electrical safety in rooms used for medical purposes.
With room temperatures > 35°C ARDET recommends the use of an air conditioning system.
Recommended operating temperature: 18 °C - 35 °
Observe accompanying documents
Accompanying documents
The following symbols are attached to the device:
Observe accompanying documents. They are attached to the unit.
Original language of the documents: English
Regular maintenance
In the interest of the safety and health of patients, users and other persons, inspection and preventive
maintenance must be performed at scheduled intervals to ensure the operational reliability and functional
safety of your product.
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, Ardet Dental Medical Devices S.r.l. and its authorized dealers cannot assume any
liability for resulting damage.
As manufacturers of medical electrical equipment we can assume responsibility for the safety-related
features of the equipment only if maintenance and repair are carried out only by ourselves or agencies
expressly authorized by us, and if components affecting safe operation of the system are replaced with
original spare parts upon failure.
We suggest that you request a certificate showing the nature and extent of the work performed from those
who carry out such work; it must contain any changes in rated parameters or working ranges (if applicable),
as well as the date, the name of the company and a signature.
Radiation protection
Only qualified and authorized personnel may operate this equipment while observing the valid radiation
protection regulations and measures.

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• Full use must be made of all radiation safety features on the equipment.
• Full use must be made of all radiation protection devices, accessories and procedures available to protect
the patient and operator from x-ray radiation.
During an exposure, the operator should move as far away from the X-ray tube assembly as the coiled cable
of the hand switch permits.
With the exception of the patient, no other persons without radiation protection are allowed to stay in the
room during an exposure. In exceptional cases, a third person may provide assistance, but not the practice
staff. Visual contact with the patient and the unit must be maintained throughout the entire exposure.
In case of malfunctions, cancel the exposure immediately by letting go of the exposure release button.
Hygiene
Suitable hygienic measures must be taken to prevent cross contamination among patients, operators and
other persons.
Before positioning the patient in the unit, you must ensure that
● all auxiliary X-ray equipment is used and prepared (sterilized and/or disinfected) in accordance with
manufacturer specifications (e.g. hygienic protective sleeves).
Compliance with the hygienic measures prevents the transmission of infections that can trigger severe
illnesses.
Trouble- ree operation
Use of this unit is permissible only if it works properly without malfunctions. If trouble-free operation cannot
be ensured, the unit must be taken out of service, checked by authorized technicians for malfunctions and, if
necessary, repaired.
Quali ications o operating personnel
The system may only be operated by skilled or properly trained personnel.
Condensation
Extreme fluctuations of temperature may cause condensation inside the unit. Do not switch the unit on before
it has reached normal room temperature. See the chapter on “Technical data”.
Modi ications to the unit
Modifications to this unit which might affect the safety of the system owner, patients or other persons are
prohibited by law!
For reasons o product sa ety, this product may be operated only with original ARDET accessories or
third-party accessories expressly approved by ARDET.
The user assumes the risk of using non-approved accessories.
Electromagnetic compatibility
The imaging unit complies with the requirements of EN 60601-1-2.

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Medical electrical devices are subject to special precautionary measures with regard to EMC. It must be
installed and operated as specified in the document “Service Installation Manual ”.
Portable and mobile RF communications equipment may interfere with medical electrical equipment.

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2 Technical description
2.1 Alimentation
Nominal voltage 120-230 V~
Permissible deviation ± 10%
Main building fuse ETF- 630 mA / 250V
Nominal frequency 50/60 Hz
Internal line impedance ≤ 0.8 Ohm
Tubehead
Tube voltage 60 kV / 65 kV / 70 kV switchable
(max. tolerance ± 5 kV)
Tube current 5 mA (max. tolerance ± 1.4 mA)
High-voltage waveform DC high frequency, residual ripple value ≤ 4 kV
Maximum load 70 kV 7 mA 2 s
Total filtration of X-ray tube assembly > 2 Al/ 70 IEC 60522
Radiation field Ø < 60 mm
Leakage radiation at 1 m distance: < 0.25 mGy/h
X-ray tube
Type CEI OX 70-4
Manufacturer Cei Italy
Inherent filtration 0,5 mm Al equivalent at 70 kV
Focal spot 0,4 mm
Anode material Tungsten
Anode angle 16°
Nominal voltage 70
Anodic thermal capacity 7 kJ
Type TOSHIBA D-041
Manufacturer Toshiba Japan
Inherent filtration 1 mm Al equivalent at 70 kV
Focal spot 0,4 mm
Anode material Tungsten
Anode angle 12,5°
Nominal voltage 70
Anodic thermal capacity 4,3 kJ

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Timer
Irradiation time 0.01 – 2.0 s (max. tolerance ± 10% +1 ms)
Duty cycle 1:60
Focal spot marking O O
Source skin distance 200 mm standard
Class equipment I with type B applied parts
Degree of protection against ingress of water Ordinary equipment IP20
Year and month of manufacture XXXXXXXXXX-YYYY (on the rating plate)
Operating mode Continuous operation with intermittent, stated permissible
loading/rest time
Weights
Gross weight 30,5 Kg
Net weight (wall mount unit) 25,5 Kg
Tubehead 6,5 Kg
Timer 1,5 Kg
Wall Plate 3 Kg
Double Counterbalanced Arm 11 Kg
Horizontal arm 50 cm 3,5 Kg
Horizontal arm 90 cm (standard) 4,5 Kg
2.2 Operating, transport and storage conditions
2.2.1 Transport and storage conditions
Temperature -10 °C – +70 °C
Relative humidity 10% – 90%
Pressure From 500 to 1060 hPa
2.2.2 Operating conditions
Temperature +10 °C – +40 °C
Relative humidity 30% – 75%
Pressure From 700 to 1060 hPa

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2.3 Rating charts
CEI OX70/4
X-ray tube thermal curves
7
3
0
kJ
0 521 3
min
1
2
4
5
6
4
Tubehead thermal curves
100
50
0
kJ
0 20 010 025 50 75 125 150 1 7 5
min
10
20
30
40
60
70
80
90

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TOSHIBA D-041
X-ray tube thermal curves
7
0
kJ
0 41
min
1
3
2 3
6
5
4
2
Tubehead thermal curves
100
50
0
kJ
0 20 010 025 50 75 125 150 1 7 5
min
10
20
30
40
60
70
80
90

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3 Controls and unctional elements
3.1 Operating and Display Elements
01 Display
02 Manual decrease
03 Manual increase
04 Selection mode for Kv and film/psp/rvg
05 Patient size selection key
06 Tooth/technique selection key
07 Indication of system turned on and ready
08 Exposure /Confirm
09 Irradiation

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3.2 Meaning o the icons
Large patient
Medium patient
Small patient
Up arrow
Down arrow
Selection key
Exposure release button
Lower (mandibular) Premolars Molars
Upper (maxillary) Premolars Molars
Lower (mandibular) Canine
Upper (maxillary) Canine

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Upper (maxillary) /Lower (mandibular)
Incisive
Exposure
Ready
3.3 Exposure times
3.3.1 Possible exposure times in seconds
Exposure times displayed in seconds can be set in free technique in steps of 10 ms between the minimum
value of 0.01 and the maximum value of 2 s
3.3.2 Pre-programmed exposure times or ilms o sensitivity class D (FILMD)
0,14 s
70 kV
0,15 s
70 kV
0,12 s
70 kV
0,12 s
70 kV
0,12 s
65 kV
0,12 s
70 kV
0,14 s
70 kV
0,11 s
65 kV
0,11 s
65 kV
0,10 s
65 kV
0,10 s
65 kV
0,12 s
65 kV
0,08 s
65 kV
0,08 s
65 kV
0,08 s
60 kV

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3.3.3 Pre-programmed exposure times or ilms o sensitivity class E (FILME)
0,10 s
70 kV
0,12 s
70 kV
0,09 s
70 kV
0,09s
70 kV
0,08 s
65 kV
0,08 s
70 kV
0,09 s
70 kV
0,08 s
65 kV
0,08 s
65 kV
0,06 s
65 kV
0,06 s
65 kV
0,08 s
65 kV
0,06 s
65 kV
0,06 s
65 kV
0,06 s
60 kV
3.3.4 Pre-programmed exposure times or ilms o sensitivity class F (FILMF)
0,05 s
65 kV
0,06 s
70 kV
0,04 s
65 kV
0,04 s
65 kV
0,04 s
65 kV
0,04 s
65 kV
0,06 s
65 kV
0,03 s
65 kV
0,03 s
65 kV
0,03 s
60 kV
0,04 s
65 kV
0,05 s
65 kV
0,03 s
65 kV
0,03 s
65 kV
0,03 s
60 kV