Air Techniques PRO VECTA HD Operating Instructions Manual
Air Techniques PRO VECTA HD is an intraoral dental X-ray system that provides high-quality images for accurate diagnosis and treatment planning. With its advanced features and user-friendly design, the PRO VECTA HD is an excellent choice for any dental practice.
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P R O V E C T A
®
H D
Intraoral Dental X-Ray System
Operating Instructions
Contents
Important information
1 Documentation 2
26 Protection against electrical current 3
Usage
91 Standard settings on switch-on 15
92 Positioning patient, X-ray unit and image receptor 17
93 Activate exposure 18
10 Cleaning and disinfecting 19
Troubleshooting
11 Tips for Operators and Technicians 20
Product description
41 X-ray tube performance data 8
43 Model identification plate 10
53 Radiation field collimation 12
Annex
12 Leakage Dose Test Report 22
13 Information on EMC according to
133 Guidelines and manufacturer's information 24
14 Recommended maintenance schedule 29
Warranty
30
Setup
72 Mount radiation field collimation 13
73 Safety for the electrical connection 13
74 Connecting the appliance to the power supply 13
Air Techniques, Inc.
Page 1
Important information
1 Documentation
This document forms an integral part of the unit
It provides setup and operating information that conforms to the relevant version of the equipment and the status of technology valid at the time of first operation All operators must read and understand this manual prior to using the device
Air Techniques cannot guarantee smooth operation and safe function of the unit and will not accept any liability where the instructions and notes contained in these installation and operating instructions are not strictly observed
1.1 Warnings and symbols
Warnings
The warnings in this document are there to point out possible injury to persons or damage to machinery
The following warning symbols are used:
General warning symbol
Warning - dangerous electrical voltage
Federal law restricts this device to sale by or on the order of a dentist licensed by the law of the State in which he practices to use or order the use of the device Use of this device, other than as described in this manual, may result in injury
Additional symbols
These symbols are used within the documentation and on the unit itself:
Notes, eg special instructions concerning economical use of the unit
Observe the accompanying documentation
CSA certification mark in accordance with CAN/CSA C222 No6011 regulations
IEC 60601-1 (3rd Ed)
IEC/EN 60601-1-1, IEC/EN 60601-1-2
IEC/EN 60601-1-3, IEC/EN 60601-2-65
CE Labeling Warning - X-rays
The warnings are structured as follows:
SIGNAL WORD
Description of type and source of danger
Possible consequences of ignoring the safety warning here
• Measures to be taken to avoid any possible danger
The signal word differentiates between different levels of danger:
– DANGER
High risk of danger of serious injury or death
– WARNING
Possible risk of danger of serious injury or death
– CAUTION
Risk of danger of minor injuries
– NOTICE
Risk of serious damage
Page 2
Manufacturer
Class I Type B
Wear protective gloves
Date of
Manufacture
Switch off the device (i e unplug and disconnect from mains)
Air Techniques, Inc .
1.2 Notes on copyright
All circuits, processes, names, software and appliances quoted are protected under industrial property rights
Any reprinting of the technical documentation, in whole or in part, is subject to prior approval of
Air Techniques being given in writing
2 Safety
This unit has been so designed and developed that under normal and proper usage any possibility of damage or injury can be virtually ruled out However, there is always a small margin of risk Please observe the following instructions carefully
2.1 Correct use
This unit is designed solely for using intraoral x-rays in the examination and diagnosis of diseases and illnesses of teeth, jaw and the oral cavitiy
2.2 Incorrect use
Any use of this appliance above and beyond that specifically described in these instructions will be deemed to be as not according to the intended use The manufacturer cannot be held liable for any damage resulting from incorrect usage The user bears all risks
2.3 General safety notes
• Before using the appliance observe any and all guidelines, laws, regulations and other restrictions which may apply to the appliance
• Before each use check the function and condition of the appliance
• Do not convert or change the appliance in any way
• Observe the Installation and Operating Instructions precisely
• Keep the Installation and Operating Instructions in an accessible place so that the operator has instant access to them
2.4 Radiation protection
• Observe all mandatory current x-ray protection rules and take all necessary x-ray protection measures
• Use proscribed x-ray protection equipment
• In order to reduce the amount of x-ray exposure, we recommend the use of bismuth, lead
Air Techniques, Inc.
Important information shielding or protective aprons, especially for children and teenagers
• Any operative personnel must remain at least
15 m from the x-ray unit when taking any radiographs
• Within the radiation room there must be no other person present beside the patient without x-ray protection measures In exceptional circumstances a third party may be present to give assistance, but this must not be a member of the surgery staff Ensure visual contact during exposure with the patient and the unit
• In the case of any interruption when taking an exposure, stop the procedure immediately by letting go of the release switch
2.5 Qualified personnel
Instructions for use
Persons who operate the appliance must, on the basis of their training and knowledge, ensure safe and correct handling of the appliance
• Ensure personnel are trained in the correct usage of the appliance
Installation and repair
• Installation, resetting, alterations, extensions and repairs must be carried out by Air Techniques or by qualified personnel specifically approved and authorized by Air Techniques
2.6 Protection against electrical current
• When working on and with the appliance always observe the local electrical safety procedures
• Never come into contact with patients and open plug-in connections on the appliance at the same time
• Damaged supply lines and connections must be replaced immediately
2.7 Only use original parts
• Only Air Techniques parts or accessories and special accessories specifically approved by
Air Techniques may be used
• Only use original working parts and spare parts
Page 3
Important Information
Air Techniques cannot accept any liability for damage caused by the use of accessories and special accessories not specifically approved by Air Techniques or not using original working parts and spare parts
2.8 Transport
The original packaging offers the optimum protection for the appliance during transport
If required, the original packaging for the unit can be ordered at Air Techniques
Air Techniques cannot accept any liability for damage caused during transport by the use of unsuitable packaging, this is also valid during the warranty term
• Only transport the appliance in its original packaging whenever possible
• Keep the packing materials out of the reach of children
2.9 Disposal
The equipment contains - in some of its parts
- solid and liquid substances which must be disposed of at appropriate recycling centers conforming to all local, state and federal regulations
In particular, the equipment contains the following materials and/or components:
Tubehead:
Non-biodegradable plastic materials, metals, glass, dielectric oil, lead, tungsten
Other parts:
Non-biodegradable plastics, metals, printed circuits, and electronic components
Air Techniques is not responsible for disposal of the apparatus or parts thereof and for the related expenses
Page 4 Air Techniques, Inc .
Product description
3 Overview
7
6
5
4
3
1 X-ray tube head
2 Cone (collimator)
3 Main power switch
4 Control unit with control panel
5 Handheld exposure button
6 Horizontal Arm
7 Scissor Arm
2
1
Air Techniques, Inc.
Page 5
Product description
3.1 Delivery Contents
The following articles are included in the scope of delivery
Provecta HD X-ray unit with short extension arm . . . . . . . . . . . . . . . . . A6350-15
Provecta HD X-ray unit with medium extension arm . . . . . . . . . . . . . A6350-24
Provecta HD X-ray unit with long extension arm . . . . . . . . . . . . . . . . . A6350-33
– X-ray tubehead
– Scissor arm
– Horizontal arm
– Control unit with control panel
– Exposure button and holder
– X-ray collimator 12 x 16 in 2
– Mains cable (110 V)
– Installation Mounting Hardware
– Installation and Operating Instructions
3.2 Special accessories
The following items can be optionally used with the appliance:
Single stud wall mount plate kit A6336
16 on center wall mount plate kit A6330
X-ray collimator, rectangular
08 x12 in 2 A6346
Extension cone, 12 inches (300 mm) A6395
Wallplate exposure pushbutton switch kit A6320
Control panel remote mounting kit A6400
Commissioning and intraoral constancy checks
2-D X-ray test phantom G8795
Page 6 Air Techniques, Inc .
Product description
4 Technical data
Unit electrical data
Nominal voltage
Max voltage fluctuation
Frequency
Power rating
Maximum power
100 to 240 V AC
±10%
50/60 Hz
500 W
750 VA
Classification
FDA 21 CFR Device Classification
This X-ray system complies with US - FDA:
Class II
Degree of protection against ingress of water
21 CFR Part 10102
21 CFR Part 102030/31
Ordinary
Medical products directive (93/42/EEC) manufacturer: VATECH Co, Ltd
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea 445-170
X-ray unit technical data
X-ray Tube Type
Model
Generator size and weight
Source to skin distance
Generator performance
Nominal voltage (Accuracy)
Nominal current (Accuracy)
X-ray tube cooling
Inherent filtration
Total filtration
Focal spot size according to IEC 60336
X-ray field collimation
Exposure time (Accuracy)
Anode material
Anode angle
Duty cycle
Toshiba D-041SB (Stationary Anode Type)
DG-10A05T3
55 x 6 x 3 in (140 x 150 x 70 mm)
55 lbs (25 kg)
8 in (200 mm) 12 in optional (300 mm)
05 kW
50 to 70 kVp (±10%)
Values below 60 kV are not intended for human use in USA and Canada
4 to 7 mA (±20%)
Automatically controlled ≥ 50 °C
Air cooling: optional
10 mm Al
Min 20 mm Al
04 mm
∅ 24 in/12 x 16 in 2 ( ∅ 60 mm/30 x 40 mm 2)
Optional 08 x 12 in 2 (20 x 30 mm 2 )
004 to 2 seconds (±5% or ±20 ms)
Tungsten
125 degrees
1:60 or greater
Air Techniques, Inc.
Page 7
Product description
4.1 X-ray tube performance data
Monoblock Cooling Curve
45
40
35
30
25
20
15
10
5
0
1 11 21 31 41 51 61 71 81
TIME [min]
91 101 111 121 131 141 151
General technical data
Arm length
Storage height
Weight
A6350-15 A6350-24 A6350-33
177 in (450 mm) 236 in (600 mm) 354 in (900 mm)
45 in (1156 mm)
55 lbs (249 kg) 56 lbs (254 kg) 59 lbs (267 kg)
Ambient conditions during operation
Temperature
Relative humidity
Air pressure
50 to 95 °F
(+10 to +35 °C)
30 to 75%
25 to 31 inHg (860 to 1060 hPa)
Ambient conditions during storage and transport
Temperature
14 to 140 °F
Relative humidity
Air pressure
(-10 to +60 °C)
10 to 75%
25 to 31 inHg (860 to 1060 hPa)
Page 8 Air Techniques, Inc .
4.2 Dimensions
See Horizontal Arm
Length Below
Product description
180
ο
280
ο
A
B
46 in.
(1168 mm)
46 in.
(1168 mm)
11.4 in.
(290 mm)
C
D
380
ο
21 in.
(524 mm)
E
F
DIMENTIONS 'A' THRU 'E' :
SINGLE POST WALL MOUNTING PLATE (P/N A6389) - ADD 05" (13mm)
16 CENTER TO CENTER WALL MOUNTING PLATE (P/N A6341) - ADD 10" (26mm)
Horizontal Arm length
177 inches
(450 mm)
PN A6350-15
236 inches
(600 mm)
PN A6350-24
354 inches
(900 mm)
PN A6350-33
A
503 inches
(1278 mm)
56 inches
(1422 mm)
244 inches
(620 mm)
302 inches
(767 mm)
665 inches
(1689 mm)
5625 inches
(1429 mm)
B
6175 inches
(1568 mm)
C
31 inches
(787 mm)
D
365 inches
(927 mm)
685 inches
(1740 mm)
73 inches
(1854 mm)
42 inches
(1068 mm)
48 inches
(1219 mm)
E
7175 inches
(1823 mm)
833 inches
(2118 mm)
F
86 inches
(220 mm)
86 inches
(220 mm)
86 inches
(220 mm)
Air Techniques, Inc.
Page 9
Product description
4.3 Model identification plate
Appliance
The model identification plate is located on the rear side of the control unit housing
6.0 in.
(151.2 mm)
G
40.1 in.
(1019 mm)
46 in.
(1168 mm)
REF Order number
SN Serial number
UDI Unique device identification code
X-ray unit
The model identification plate is located on the rear side of the x-ray unit
10.6 in.
(269 mm)
H
Horizontal Arm length
177 inches
(450 mm)
PN A6350-15
236 inches
(600 mm)
PN A6350-24
354 inches
(900 mm)
PN A6350-33
G
292 inches
(7425 mm)
351 inches
(8925 mm)
48 inches
(12192 mm)
H
(Head Turned in)
H
(Head Turned out)
321 inches
(8147 mm)
350 inches
(890 mm)
37 inches
(940 mm)
41 inches
(1040 mm)
50 inches
(1270 mm)
53 inches
(1346 mm)
REF Order number
SN Serial number
Page 10 Air Techniques, Inc .
Product description
5 Function
Provecta HD is an extraoral x-ray unit and is factory set at the correct x-ray dosage for each dental area required using Air Techniques image plates and sensors It consists of a control unit, an arm extension system and an x-ray tube assembly
The handle on the x-ray head unit allows the x-ray tube to be positioned precisely
5.1 Control panel
9
8
1
2
3
4
7
3
4
5
1
2
LED Display
Anatomical selector
Parameter adjustment key
Adult/Child selector
X-Ray emission indicator
6 5
8
9
6
7
Exposure button
Stand-by/Power indicator
Save key
Image plate/sensor selector
Air Techniques, Inc.
Page 11
Product description
Menu tooth symbol
Front tooth
Molar
Pre-molar
Bite wing exposure
Menu x-ray parameter kV -> mA -> sec
To enter the following parameters press or kV: 60 to 70, 50 to 70 (optional) mA: 4 to 7 secs: 004 to 2
Menu Adult/Child
Adult
Child
Menu image plate/sensor
Image plate
Sensor
5.2 Exposure switch
The exposure switch can be used as alternative to using the control panel to activate irradiation
5.3 Radiation field collimation
The radiation field collimator reduces the useful x-ray field to the required dimensions This reduces the x-ray exposure to the patient Observe any national regulations
5.4 Wall mounting plate
A wall mounting plate must be used for Provecta HD installations There are two mounting plates available; one for single stud installations and a 16 on center plate used when there are dual studs
Refer to the Installation manual for instructions to install the Provecta HD unit
Page 12 Air Techniques, Inc .
Setup
Only fully-qualified or from Air Techniques trained personnel may set-up, install or operate this appliance
6 Prerequisites
The room chosen for set up should fulfil the following requirements:
Closed, dry room
– Should not be a room made for another purpose (e g boiler room or wet cell)
– No large fields of interference (e g strong magnetic fields) present, that can interfere with the function of the unit
– Take environmental conditions into consideration section 4, Technical data"
2
1
7 Tube and Power Setup
7.1 Mount tube (optional)
• Place the 12 in (30 cm) tube extension in position and check whether the grooves match correctly
2
1
7.2 Mount radiation field collimation
• Slide the radiation field collimator piece onto the tube and adjust according to the image plate or the sensor
7.3 Safety for electrical connection
• The appliance may only be connected to a correctly installed electrical socket outlet
• Do not lay multi-socket units on the floor Specifications of IEC 60601-1-1 apply
• Other systems should not be plugged into the same multi-socket unit
• All cables, etc must be laid so that no mechanical tension is exerted on them
• Before start-up or first use, check the mains voltage against the voltage indicated on the model identification plate (see also "4 Technical
Data")
7.4 Connecting the appliance to the power supply
Requirements:
9 A correctly installed socket-outlet in the vicinity of the unit must be available (maximum length of mains cable 6 ft (18 m)
9 The socket-outlet must be easily accessible
9 Voltage is identical to that given on the model identification plate
9 Insert plug into electrical socket
Air Techniques, Inc.
Page 13
Setup
8 Operation
The necessary tests (e g acceptance test) are regulated by the locally applicable national law
• Find out which tests are to be made
• Carry out tests in accordance with national law
8.1 Operational check
When carrying out the commissioning tests where the image plate and sensor are used as receiver, the 2-D X-ray test phantom is required and possibly the appropriate 2-D X-ray test phantom holder
• Before initial unit operation the commissioning test of the x-ray system must be carried out according to national regulations
The tests of constancy, which must be carried out at regular intervals by the surgery personnel, are based on the results of the commissioning test
8.2 Electrical safety check
• Carry out an electrical safety check according to all national regulations (eg patient conductivity, conductivity of housing)
• Document the results
8.3 Switch unit on
The display will show the standard values for x-ray exposures or the setting values used for the last exposure carried out
– Operational display lamps,
– LED for menu tooth symbol,
– LED for menu Adult/Child and
– LED for menu image plate/sensor all light up
8.4 Service menu settings
• While pressing the button and additionally the button a little longer in order to switch to the
Service-menu
• Under menu option 1 Cone Type move to appropriate value with or scroll through and then use to confirm
• Under menu option 2 Cone Type move to appropriate value with or scroll through and then use to confirm
• Under menu option 3 Default Value Reset , press to confirm reset
• Under menu option 4 kV Option move to appropriate value with or scroll through, 50-70 kV are permissible in countries with no x-ray limit regulations Use to confirm
• Under menu option 5 X-ray Count move to appropriate value with or scroll through Use to confirm
Resetting the counter is password protected
• Under menu option 6 Version the current Firmware Version can be called up Use to confirm
• Under menu option 7 Demo the Demo-Version can be started by pressing
• After entering all required values press to exit the Service Menu
Page 14 Air Techniques, Inc .
Usage
9 Instructions for use
NOTICE
Exerting force on the unit can lead to it becoming damaged
• Do not lean against or support yourself using the unit
9.1 Standard settings on switch-on
The tube length can be preset in the Service-Menu "84 Service menu settings"
An extension of the tube influences the image quality and the dose area product displayed
Standard settings on switch-on
– Image plate
– Adult, Pre-molar
– 60 kV, 7 mA
The following table shows the standard values for the image plate exposure time of an adult patient
Incisor
Pre-molar
Molar
Bite wing
DC radiator, 7 mA
Tube length 8 in. (20 cm)
60 kV µGy
008 s
012 s
017 s
018 s
107
156
215
227
DC radiator, 6 mA
Tube length 12 in. (30 cm)
70 kV
013 s
018 s
025 s
027 s
µGy
109
147
207
223
The following table shows the standard values for the image plate exposure time of a child patient
Incisor
Pre-molar
Molar
Bite wing
DC radiator, 7 mA
Tube length 8 in. (20 cm)
60 kV µGy
005 s
007 s
011 s
011 s
67
94
146
146
DC radiator, 6 mA
Tube length 12 in. (30 cm)
70 kV
008 s
011 s
014 s
014 s
µGy
67
93
144
144
• Check and adjust X-ray appliances in accordance with the following standard equipment-specific values
The following table shows the standard values for the sensor exposure times for an adult patient
Incisor
Pre-molar
Molar
Bite wing
DC radiator, 7 mA
Tube length 8 in. (20 cm)
60 kV
007 s
µGy
93
010 s
013 s
014 s
132
162
174
DC radiator, 6 mA
Tube length 12 in. (30 cm)
70 kV
011 s
µGy
91
016 s
020 s
021 s
131
164
172
Air Techniques, Inc.
Page 15
Usage
The following table shows the standard values for the sensor exposure time of a child patient
Incisor
Pre-molar
Molar
Bite wing
DC radiator, 7 mA
Tube length 8 in. (20 cm)
60 kV
004 s
µGy
51
006 s
008 s
009 s
81
108
121
DC radiator, 6 mA
Tube length 12 in. (30 cm)
70 kV
007 s
010 s
013 s
014 s
µGy
58
82
107
115
• Check and adjust X-ray appliances in accordance with the following standard equipment-specific values
Pre-programmed exposure times for films with class E sensitivity on an adult patient
Incisor
Pre-molar
Molar
Bite wing
DC radiator, tube length
8 in. (20 cm)
7 mA
60 kV
6 mA
70 kV
016 s
020 s
025 s
008 s
010 s
012 s
032 s 016 s
DC radiator, tube length
12 in. (30 cm)
7 m A
60 kV
032 s
040 s
050 s
064 s
6 mA
70 kV
016 s
020 s
025 s
032 s
Pre-programmed exposure times for films with class E sensitivity on a child patient
Incisor
Pre-molar
Molar
Bite wing
DC radiator, tube length
8 in. (20 cm)
7 mA
60 kV
010 s
6 mA
70 kV
005 s
012 s
016 s
020 s
006 s
008 s
010 s
DC radiator, tube length
12 in. (30 cm)
7 mA
60 kV
020 s
025 s
032 s
040 s
6 mA
70 kV
010 s
012 s
016 s
020 s
• Check and adjust X-ray appliances in accordance with the following standard equipment-specific values
• Press selection key image plate/sensor
• Press selection key tooth symbol
• Press selection key Adult/Child patient
• Press selection key imaging parameters
– kV, and to select other values
• Press selection key imaging parameters
– mA, and to select other values
• Press selection key imaging parameters
– secs, and to select other values
• Press key Save for 2 secs
The individual settings have now been saved and can be read on the display
To reset the unit to the factory settings please contact your Service
Technician
Page 16 Air Techniques, Inc .
9.2 Positioning patient, X-ray unit and image receptor
CAUTION
Injuries to the oral cavity
Sharp-edged receptors can cause injuries to the oral cavity
• Careful positioning of the image receptor into the patient's oral cavity
• Allow the patient to sit down
• Position the image receptor inside the oral cavity
• Position the x-ray unit
CAUTION
Image quality insufficient
If the x-ray unit is moved or if the patient moves during exposure then the images will not be usable
• The patient should sit quite still during x-ray exposure
• The x-ray unit must not be moved in any way during exposure
The image receptor can be any of the following:
– Film
– Sensor
– Image plate
Ensure that the image receptor is placed within the x-ray field
Place the tube close to the skin
Parallel techniques
Position the image receptor using a holder system for parallel techniques
1 Image receptor
2 Tooth axis
Upper jaw front tooth exposure
X-ray is projected 45° downwards
Lower jaw front tooth exposure
X-ray is projected 25° upwards
Usage
Bisection angle technique
The patient should hold the image receptor in the mouth in the correct position The middle of the radiation ray is set at right angles to an (estimated) plane at half the angle between tooth axis and image receptor
2
1
1 2
1 Image receptor
2 Tooth axis
Air Techniques, Inc.
Upper jaw molar and premolar exposure
X-ray is projected 25° upwards
Page 17
Usage
Lower jaw molar and premolar exposure
X-ray is projected 5° upwards
Bite wing technique
During the bite wing exposure the patient needs to bite on a bite wing holder
X-ray is projected 5 to 8° upwards
9.3 Activate exposure
CAUTION
Injuries through x-rays
X-rays can cause tissue damage
• Observe all x-ray regulations
• Keep a minimum safety distance of 5 feet (15 m)
6 5
9
1
2
3
4
Page 18
8
7
1 LED Display 6
2 Anatomical selector
3 Parameter adjustment key
4 Adult/Child selector
5 X-Ray emission indicator
6 Exposure button
7 Stand-by/Power indicator
8 Save key
9 Image plate/sensor selector
5
NOTICE
Unit damage due to switching frequency being too high
If sufficient cooling of the x-ray unit is not ensured, this can lead to damage
• Only activate the subsequent x-ray image after the displayed cooling time has elapsed
• Check x-ray settings on control panel and change if necessary
– Change the tooth region using menu tooth symbol
– Change to adult or child using patient menu
• Check x-ray parameter and change if necessary
• Depress exposure button
– The x-ray unit control lamp lights green -> unit is warming up
– The control lamp lights orange and an acoustic signal is heard -> unit is exposing
Air Techniques, Inc .
Hold the exposure button at least as long as the acoustic signal can be heard Otherwise the exposure will be faulty and there will be an error message in the display
– The image is ready as soon as the exposure time has passed The x-ray unit control lamp goes out and the acoustic signal is no longer heard
– The dose area product is shown on the display, when this function is enabled in the service menu
The unit cools down after every exposure The cooling time is clearly displayed as it reduces During this time the activation release can no longer be operated The x-ray unit control lamp blinks
– The unit is ready again
Air Techniques, Inc.
Usage
10 Cleaning and disinfecting
NOTICE
Unsuitable agents and methods can damage the appliance and accessories
• Only use the disinfection and cleaning agents specified or approved by Air
Techniques
• Observe the instructions for use of the disinfection and cleaning agents
Wear protective gloves
Prior to work on the appliance, pull the mains plug
The unit surface must be cleaned and disinfected of contamination or soiling Using approved cleaning and disinfectant agents
NOTICE
Liquid can cause damage to the appliance
• Do not spray the appliance with cleaning and disinfectant agents
• Make sure that liquid does not get inside the appliance
• Remove any soiling with a soft, wet, lint-free cloth
• Disinfect the surfaces using a disinfectant wipe Alternatively use a spray disinfectant on a soft, lint-free cloth Observe the disinfectant instructions for use
Clean the outside surfaces of the unit by wiping with a soft lint-free cloth dampened with a mild non-abrasive household dish detergent or use a use a quick-acting cleaning agent such as Birex, or Isopropyl II Alcohol 70% wipes Be careful not to allow liquids to run or pool
The following should not be used:
CaviWipes towelettes,
CaviWipes 1 towelettes,
Sani-Cloth wipes, Volo Surface wipes,
Opti Cide 3 surface wipes,
Optim 33TB wipes,
Clorox germicidal wipes,
Maxiwipe germicidal cloth
Page 19
Troubleshooting
11 Tips for Operators and Technicians
Repairs above and beyond simple maintenance may only be carried out by a qualified technician or one of our service technicians
Problem
E01
E02
E03
E08
E09
E10
E11
E12
E13
E14
E15
Page 20
Probable cause Solution
Electrical connection between the control panel and PCB (main board) is interrupted
• Switch the appliance off
• Check the connection cable
• Inform service technician
Electrical connection between the x-ray unit and PCB (main board) is interrupted
• Switch the appliance off and on
• Inform service technician
Current strength exceeded maximum permitted value during exposure
X-ray unit temperature too high
• Switch the appliance off and on
• Inform service technician
Current strength outside permitted value during exposure
• Switch off the x-ray unit until it has cooled down sufficiently
• Switch the appliance on again
• Switch the appliance off and on
• Inform service technician
X-ray exposure not activated despite key being pressed
Exposure continues more than
05 secs, even though activation switch no longer pressed
Displayed kV-value is lower than the value actually set
Displayed kV-value is higher than the value actually set
• Quit by pressing key "Menu xray parameter"
• If the fault repeats, inform your
Service Technician
• Switch the appliance off
• Inform service technician
• Switch the appliance off and on
• If the fault continues to be displayed, inform your Service
Technician
• Switch the appliance off and on
• If the fault continues to be displayed, inform your Service
Technician
Displayed mA-value is lower than the value actually set
• Switch the appliance off and on
• If the fault continues to be displayed, inform your Service
Technician
Displayed mA-value is higher than the value actually set
• Switch the appliance off and on
• If the fault continues to be displayed, inform your Service
Technician
Air Techniques, Inc .
Problem
E60
E61
Value over
Troubleshooting
Probable cause Solution
Activation switch is released while unit is being turned on
• Switch the appliance off and on
Take care that the activation key is not being pressed
• Inform service technician
Activation switch is released, before the set exposure time has been expired
Operating error kV value or time entered is too high
• Quit by pressing key "Menu xray parameter"
• If the fault repeats, inform your
Service Technician
• Correct the value
Problem
Unit does not start up
No x-ray irradiation
X-ray image too bright
X-ray image too dark
Probable cause
No mains supply
Solution
• Check mains cable and sockets and change if necessary
• Inform service technician
• Check main fusing in building
On / off switch is defect
X-ray unit temperature too high
• Inform service technician
• Wait until x-ray unit has cooled down sufficiently
• Inform service technician Activation key on control panel is defect
Activation key on manual release is defect
• Cable is defect or not connected to unit
• Inform service technician
Image receptor being used not compatible with unit settings
• Wait until x-ray unit has cooled down sufficiently
X-ray unit not positioned correctly • Correct the position of the x-ray unit
X-ray parameters not set correctly • Check x-ray parameters and, if necessary, set correctly
Increase exposure time
• Inform service technician
Image receptor not correctly placed in patient's mouth
• Correct the position of the image receptor
Image receptor being used not compatible with unit settings
• Use different image receptor or change unit settings
X-ray parameters not set correctly • Check x-ray parameters and, if necessary, set correctly Reduce exposure time
• Inform service technician
Air Techniques, Inc.
Page 21
Annex
12 Leakage Dose Test Report
12.1 General notes
The X-ray does data is extracted from the X-ray Dose Test Report for the ProVecta HD The X-ray doses of ProVecta HD in the test report were measured in accordance with the IEC collateral standards ProVecta HD was designed in accordance with Part 1 Generatl Requirements for Safety, IEC
60601-1-3
12.2 Leakage Dose Test
Test Equipment Information
Instrument
Dose Meter
Manufacture
Victoreen
Model
660
S/N
101114 / 101377
Direction [°]
135
180
225
270
315
0
45
90
Test Condition
Distance from focal point [m]
Applied tube Voltage Peak [kVp]
Applied Tube Current [mA]
Applied Exposure time [s]
1
70
60
05
Transverse
00018
00140
00482
00105
00035
00105
00544
00702
Basic Cone [mGy/hr]
Longitudinal
00605
00395
00535
00561
00947
00561
00614
00509
The tested area on the plane of radiation is defined within a radius at a distance of 1m from the focal spot
Page 22 Air Techniques, Inc .
Annex
[Measurement Points (Transverse / Longitudinal)]
[Measurement Values (Transverse)]
[Measurement Values (Longitudinal)]
Air Techniques, Inc.
Page 23
Annex
13 Information on EMC according to EN 60601-1-2
13.1 General notes
The information in this leaflet includes excerpts from the relevant European standards for electrical, medical appliances The information reproduced here should be observed during the installation of individual appliances and when combining Air Techniques appliances with products of other manufacturers If there is any question of doubt, the complete standard must be checked
13.2 Abbreviations
EMC Electro-magnetic compatibility
HF High frequency
U
T
V
1
, V
2
E
1
P d
Voltage rating of appliance (supply voltage)
Level of consistency for testing according to IEC 61000-4-6
Level of consistency for testing according to IEC 61000-4-3
Rated power of transmitter in watts (W) according to manufacturer's information
Recommended safety distance in metres (m)
13.3 Guidelines and manufacturer's information
Electromagnetic transmissions for all appliances and systems
The appliance is designed for operation in one of the electromagnetic environments as outlined below The customer/operator of such an appliance is obliged to ensure that the appliance is operated in such an environment
Interference measurements
HF transmissions according to CISPR 11
According to
Group 1
Electro-magnetic environment – guidelines
HF transmissions according to CISPR 11
HF transmissions according to CISPR 11
Harmonic limits according to IEC 61000-3-2
Voltage fluctuations/flicker according to IEC 61000-
3-3
Group 2
Class [A or
B]
[Class A, B,
C, D or Not
Applicable]
[Fully compatible or not applicable]
The appliance employs HF energy exclusively for internal functions Therefore, any HF transmissions are of extremely low nature and it is highly improbable that any other electronic components will receive any interference
The appliance must transmit electromagnetic energy in order to fulfil the functions for which it has been designed Other electronic appliances in the vicinity could be affected
The appliance is designed for use in all types of environment including those in residential areas and other suitable areas which are connected directly to the local power supply serving residential buildings
Table 1: Electromagnetic transmissions for all appliances and systems
Page 24 Air Techniques, Inc .
Annex
Electromagnetic resistance for all appliances and systems
The appliance is designed for operation in one of the electromagnetic environments as outlined below The customer/operator of such an appliance is obliged to ensure that the appliance is operated in such an environment
Resistance to interference checks
Discharge of static electricity (ESD) according to
IEC 61000-4-2
Rapid transient electrical bursts according to
IEC 61000-4-4
Surges according to
IEC 61000-4-5
Voltage drops, interruptions and fluctuations according to
IEC 61000-4-11
Magnetic field under supply frequency
(50/60 Hz) according to IEC 61000-4-
8
IEC 60601 - test levels
± 6 kV contact discharge
± 8 kV discharge to air
± 2 kV for mains connections
± 1 kV at input and output connections
± 1 kV voltage external-external conductor
± 2 kV voltage external-ground conductor
< 5% U
T
(> 95% retardation of U
T
1/2 period
) for
40% U
T
(60% retardation of U
T
) for 5 periods
70% U
T
(30% retardation of U
T
) for 25 periods
< 5% U
T
(> 95% retardation of U
T s
) for 5
3 A/m
Level of consistency
± 6 kV contact discharge
± 8 kV discharge to air
± 2 kV for mains connections
± 1 kV at input and output connections
± 1 kV push-pull voltage
± 2 kV push-pull voltage
< 5% U tardation of U
T
1/2 period
40% U
T
(60% retardation of U
T
) for 5 periods
70% U
T
(30% retardation of U
T
) for 25 periods
< 5% U
T
(> 95% retardation of U
T s
) for 5
3 A/m
T
(> 95% re-
) for
Electro-magnetic environment
– guidelines
Floors should be of wood or concrete or be covered by ceramic tiles If the floor is covered by synthetic material, the relative humidity must be at least 30%
The quality of the supply voltage should be that of a typical office building or of a hospital environment
The quality of the supply voltage should be that of a typical office building or of a hospital environment
The quality of the supply voltage should be that of a typical office building or of a hospital environment Where the operator of the appliance requires continued function even during a power out, we recommend that the appliance is supplied by an uninterrupted power supply, eg battery power
Magnetic fields of the supply voltage should have the values found in a typical office building or of a hospital environment
Table 2: Electromagnetic resistance for all appliances and systems
Air Techniques, Inc.
Page 25
Annex
Electromagnetic resistance to interference for non life-supporting appliances or systems
Portable and cordless radio appliances should not be used close to the appliance, including any electrical supply lines, as the recommended safety distance which has been calculated from the transmission frequency
Level of consistency
Recommended safety distance Resistance to interference checks
Conductive HF interference factor according to
IEC 61000-4-6
Radiated HF interference factor according to
IEC 61000-4-3
IEC 60601 - test levels
3 V eff
150 kHz to
80 MHz
3 V/m 80 MHz to
25 GHz
[V
[E
1
1
] V
] V/m d = [35 / V d = 12 ⋅ √ P d = [35 / E
MHz d = 12 ⋅ √
1
1
]
]
⋅ √
⋅ √
P
P for 80 MHz to 800
P for 80 MHz to 800 MHz d = [7 / E
1
GHz
] ⋅ √ P for 800 MHz to 25 d = 23 ⋅ √ P for 800 MHz to 25 GHz
Table 3: Electromagnetic resistance to interference for non life-supporting appliances or systems
P d
Rated power of transmitter in watts (W) according to manufacturer's information
Recommended safety distance in metres (m)
The field strength of stationary radio transmitters for all frequencies must be, according to investigation carried out on-site a lower than the consistency level b
Some interference is possible in environments surrounding appliances where the following symbol is present
Note 1
Note 2
Where 80 MHz and 800 MHz are present, the higher frequency range becomes valid
These guidelines are not applicable for all possible situations The exact amount of electro-magnetic transmissions can be considerably influenced by the rate of absorption and reflection within the building, and the presence of objects and people a The field strength of stationary transmitters, eg base station of radio telephones or cordless landline phones, amateur radio stations, on AM and FM radio or TV, cannot be theoretically exactly calculated in advance In order to establish the electromagnetic environment taking these stationary transmitters into account, a study of the electromagnetic phenomena of the actual location must be undertaken If the field strength measured at the location where the appliance is used exceeds the above level of consistency, the appliance should be observed in order to demonstrate the intended function
If any unusual behaviour of the appliance is observed, additional steps will be required, eg changing the orientation or location of the appliance b The field strength is less than [V
1
] V/m over the frequency range of 150 kHz to 80 MHz
Page 26 Air Techniques, Inc .
Annex
Recommended safety distances between portable and mobile HF communications devices and the appliance
The appliance is designed for operation in one of the electromagnetic environments as outlined below in which the HF interference is controlled The customer/operator of the appliance can help to prevent electromagnetic interference by maintaining minimum distances as recommended between portable and mobile HF communications devices (transmitters) and the appliance as outlined below according to the maximum output of the communications device
Rated power of transmitter (W)
001
01
1
10
100
012
Safety distance dependent on transmission frequency (m)
150 kHz to 80 MHz d = 1.2 ⋅√ P
80 MHz to 800 MHz d = 1.2
012
⋅√ P
800 MHz to 2.5 GHz d = 2.3
023
⋅√ P
038
12
38
12
038
12
38
12
073
23
73
23
Table 4: Recommended safety distances between portable and mobile HF communications devices and the appliance
For transmitters whose maximum rated current is not included in the table above the recommended safety distance d in metres (m) can be calculated using the following mathematical formula and the appropriate column, where P is the maximum rated current of the transmitter in watts (W) according to the information of the manufacturer of the transmitter
Note 1
Note 2
Where 80 MHz and 800 MHz are present, the higher frequency range becomes valid
These guidelines are not applicable to all possible situations The exact amount of electro-magnetic transmissions can be considerably influenced by the rate of absorption and reflection within the building and the presence of objects and people
Air Techniques, Inc.
Page 27
001
01
1
10
100
P
V
1
E
1
Annex
P :
V
1
:
E
1
:
13.4 Table of calculation
If the measured values deviate from the standard, the values in Section 4 Technical data are specified
The safety distances can then be calculated in the tables shown below
Rated power of transmitter in watts (W) according to manufacturer's information
Level of consistency for testing according to IEC 61000-4-6
Level of consistency for testing according to IEC 61000-4-3
Resistance to interference checks
Conductive HF interference factor according to
IEC 61000-4-6
Radiated HF interference factor according to
IEC 61000-4-3
IEC 60601- test levels
3 V eff
150 kHz to 80 MHz
3 V/m
80 MHz to 25 GHz
Level of consistency
[V
1
] V
[E
1
] V/m
Recommended safety distances d = [35 / V
1
] ⋅ √ P d = [35 / E
1
] ⋅ √ P
For 80 MHz to 800 MHz d = [7 / E
1
] ⋅ √ P
For 800 MHz to 25 GHz
Rated power of transmitter (W)
Safety distance dependent on transmission frequency (m)
150 kHz to 80 MHz d = [3.5/V
1
] ⋅√ P
80 MHz to 800 MHz d = [3.5/E
1
⋅√ P
800 MHz to 2.5 GHz d = [7 / E
1
] ⋅√ P
Page 28 Air Techniques, Inc .
14. Recommended maintenance schedule
Contact your local Air Techniques authorized dealer for service Only trained technicians from an authorized dealer may service the unit
Prior to working on the appliance or in case of danger, disconnect it from the mains (e g pull the plug)
• Do not keep the device and parts in a humid place
• Keep the device and parts in an appropriate place to maintain them in good condition
• They may be influenced by environmental factors such as temperature, lights, ventilation, dust, salt and so on
• Please check the ground connection of the device
• Do not try to fix the device including wires and cables by yourself It may cause accidents and damage to the device
Maintenance interval
Daily
Maintenance work
• Clean all components that come into contact with the patient and operator with and alcohol-based solution
• Wipe the outer covers of the equipment with a dry cloth at the end of each day's operation
Do not use detergents or solvents to clean the outer covers of the equipment.
Weekly
Monthly
• Ensure that the main power switch has been turned off after using the equipment
• Ensure that the equipment is firmly plugged into a dedicated power source
• Ensure that there are no oil leaks
• Ensure that the wall framework is securely attached to the wall
• Ensure that the plug and power cord are not hot
• Ensure that the power supply cable is in good condition
• Ensure that the audible signal is audible and the x-ray emission light is visible when you make an exposure
• Ensure that the orange(exposure) indicator light turns on when the exposure switch is pressed
• Ensure that the power cable is not kinked, broken, exposed and that it is free of all other defects
• Ensure that all visible lables are intact and legible
• Ensure that the equipment is well grouned
• Ensure that there is no wear or damage to the exposure switch cable
Air Techniques, Inc.
Page 29
Warranty
Provecta HD is warranted to be free from defects in material and workmanship from the date of installation for a period of 2 years (24 months) Provecta HD is designed solely for use in a dental office environment and this warranty is not applicable to other applications
All part and component returns and replacement of equipment under warranty require a Return
Materials Authorization (RMA) Items returned without an RMA, or included with other products for which an RMA has been issued, may be returned to the customer at the discretion of Air Techniques
Any item returned under warranty, will be repaired or replaced at our option at no charge provided that our inspection shall indicate it to have been defective Air Techniques, Inc is not liable for indirect or consequential damages or loss of any nature in connection with this equipment Dealer labor, shipping and handling charges are not covered by this warranty
Warranty credit will not be applied to product returns that exhibit damage due to shipping, misuse, careless handling or repairs by unauthorized service personnel Credit, or partial credit, will not be issued until product/parts have been received and assessed Warranty is void if product is installed or serviced by anyone other than authorized Air Techniques dealer service personnel
This warranty is void if Provecta HD is operated with any covers removed
This warranty is in lieu of all other warranties expressed or implied No representative or person is authorized to assume for us any liability in connection with the sale of our equipment
Online Warranty Registration
Quickly and easily register your new Provecta HD online Just have your product model and serial numbers available Then go to the Air Techniques web site, www.airtechniques.com
, click the
Warranty Registration link at the top of the page and complete the registration form This online registration ensures a record for the warranty period and helps us keep you informed of product updates and other valuable information
Page 30 Air Techniques, Inc .
Notes
Air Techniques, Inc.
Page 31
Notes
Page 32 Air Techniques, Inc .
For over 50 years, Air Techniques has been a leading innovator and manufacturer of dental products. Our priority is ensuring complete satisfaction by manufacturing reliable products and providing excellent customer and technical support. Whether the need is digital imaging, utility room equipment or merchandise, Air Techniques can provide the solution via our network of authorized professional dealers. Our products are helping dental professionals take their practices to the next level.
Air Techniques’ family of quality products for the dental professional include:
Digital Imaging
• Digital Radiography
• Intraoral Camera
• Caries Detection Aid
• Intraoral X-ray
• Panoramic X-ray
• Film Processors
Utility Room
• Dry Vacuums
• Wet Vacuums
• Air Compressors
• Amalgam Separator
• Utility Accessories
• Utility Packages
Merchandise
• Surface Disinfectant
• Enzymatic Cleaner
• Hand Sanitizer and Lotion
• Waterline Cleaner
• Evacuation System Cleaner
• Imaging Accessories
• Chemistry
• Processor Accessories
Corporate Headquarters
1295 Walt Whitman Road | Melville, New York 11747- 3062
Phone: 1-800-247-8324 | Fax: 1-888-247-8481
www.airtechniques.com
© Air Techniques, Inc Copyright 2014
•
P/N A6380, Rev. 16
•
NOVEMBER 2019
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Key features
- Compact and lightweight design for easy positioning and storage
- High-resolution images for accurate diagnosis
- Wide range of exposure settings for optimal image quality
- Automatic exposure control for consistent results
- Ergonomic hand switch for comfortable operation
