Blue X IntraOs 70 User manual

IntraOs 70
X-ray Equipment
Operator’s Manual
Blue X Imaging Srl Via Idiomi
1/8
-
33
20090 Assago ITALY e
-
mail [email protected]

IntraOs 70 – Operator’s Manual
 

Blue X Imaging S.r.l.
Via Mario Idiomi 1/8-33
20090 Assago ITALY
tel.[phone]
fax [phone]
e-mail [email protected]
www.bluex.it
IntraOs 70 X-ray Equipment
Operator’s Manual – English Edition USA
Version 3.2 December2006
Printed 04/12/2006 11:20 AM
Code 69 500 01110
Blue X Imaging is committed to Total Quality.
Thank you for notifying us any error found in this document.

IntraOs 70 – Operator’s Manual
 

1. Introduction ...................................................................................4
1.1 Congratulations......................................................................4
1.2 Purpose ..................................................................................4
1.3 Equipment Classification.......................................................4
1.4 Applicable Standards.............................................................4
1.5 Obligation of the Installer......................................................5
1.6 Obligation of the User ...........................................................5
1.7 Warning .................................................................................5
2. Technical Data...............................................................................6
2.1 Tube-Head G .........................................................................6
2.2 Beam Limiting Device ..........................................................7
2.3 Mechanical System................................................................7
2.4 Weights..................................................................................8
2.5 AutoSet Timer .......................................................................9
3. Operating instructions .................................................................10
3.1 Demonstration .....................................................................10
3.2 Beam Limiting Device ........................................................10
3.3 AutoSet Timer .....................................................................10
3.4 Operation .............................................................................14
3.5 Safety...................................................................................15
3.6 Cleaning...............................................................................15
3.7 Disinfecting .........................................................................16
3.8 Functional Check.................................................................16
4. Disposing of obsolete equipment ................................................16
Appendix A System Components .......................................................17
Appendix B Icons................................................................................18
Appendix C Exposure Table ...............................................................19
Appendix D Alarm Conditions............................................................20
Appendix E Identification Labels........................................................21
Appendix F Cooling Curves................................................................22
Table of Contents

IntraOs 70 – Operator’s Manual
 
1. INTRODUCTION
1.1 Congratulations
Congratulations! You have purchased 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.
1.2 Purpose
The IntraOs 70 X-ray Equipment is design to fulfil the needs for intra-
oral radiography in the general dental practice.
The system can be configured for wall, unit or
mobile solutions and different types of timers
and tube-heads.
The features of the system make it easy to use,
and grant long life with minimum maintenance.
1.3 Equipment Classification
•FDA: IntraOs 70 is a Class II equipment (21 CFR 872-1800).
•IEC: IntraOs 70 is a Class I, type B equipment
1.4 Applicable Standards
The IntraOs 70 system configurations, all equipped with the AutoSet
timer, comply with the following standards.
IEC 601-1 General requirements for safety
IEC 601-1-2 Electromagnetic compatibility
IEC 601-1-3 General requirements for radiation protection in
diagnostic X-ray equipment
IEC 601-2-7 Particular requirements for the safety of high voltage
generators of diagnostic X-ray generators
IEC 601-2-28 Particular requirements for the safety of X-ray source
assemblies and X-ray tube assemblies for medical
diagnosis
21 CFR 1020.30 Diagnostic x-ray systems and their major components
21 CFR 1020.31 Radiographic equipment

IntraOs 70 – Operator’s Manual
 

1.5 Obligation of the Installer
Obligation of the Installer is:
•To make sure that the line voltage specified be the
Manufacturer of the equipment is available and within the
specified range.
•For safety reasons verify that a proper switch is
available to disconnect from line voltage supply when needed
during installation
•To install and test the equipment with due diligence according to
the installation instructions from the Manufacturer.
•To provide this Operator’s Manual to the User.
1.6 Obligation of the User
It is the responsibility of the User:
•To use the system following the instructions and recommendations
contained in this Operator’s Manual.
•To maintain the equipment in compliance by following the
manufacturer’s recommended maintenance schedule. Failure of the
user to properly maintain the equipment may relieve the
Manufacturer, or his Agent, from responsibility for any injury,
damage, or non-compliance which may result.
•To report promptly to the Health Authority in charge and to the
Manufacturer or to its Agent any accident involving this medical
device or any alteration in features and/or performances which
could cause death, injuries or health hazard to Patient and/or
Operator.
Important information to be gathered and to be included in the
report to the Manufacturer are the type and serial numbers of the
involved items which can be retrieved from the technical labels.
1.7 Warning
X-ray equipment produce ionising radiation that may be
harmful if not properly controlled.
It is therefore recommended that the equipment be operated
by trained personnel only, in accordance with existing law.

IntraOs 70 – Operator’s Manual
 
Make sure to carefully manoeuvre the suspension arms to position the
tube-head in order prevent harm to the fingers in areas where they may
be pinched.
Even if compliant to specifications of electromagnetic compatibility, it
is recommended not to use the equipment in presence of external
electromagnetic fields, such as those generated by cellular phones,
which might interfere with the electronic circuits of the system.
2. TECHNICAL DATA
2.1 Tube-Head G
•Line Voltage: 120 V ±10%
•Line Frequency: 50/60 Hz ±2 Hz
•Line resistance: ≤0.4 ohm
•Maximum Line Current: 8 A
•Fuse: 8 A slow blow
•X-ray insert: 3 electrodes, grid control action
OCX/70-G
RF8G070
•Focal Spot: 0.8
•Anode Angle: 19°
•Connection: by coaxial plug, with free horizontal rotation
•High Voltage Potential: 70 kVp ±5% at 120 V line voltage
•Anode Current: 7 mA ±20% at 120 V line voltage
•Duty Cycle: 1/30
•Inherent Filtration: ≥2.1 mm Al
•Radiation Leakage: < 0.1 mGy/h at 1 m (< 11.5 mR/h at 1 m)

IntraOs 70 – Operator’s Manual
 

2.2 Beam Limiting Device
•Circular Output Section
Focus Skin Distance:
8.27”(21 cm)
Output Radiation Field:
2.35” diameter (6 cm)
•Rectangular Output Section
Focus Skin Distance:
8.27”(21 cm)
Output Radiation Field:
1.8”x 1.81” (3.5 x 4.6 cm)
2.3 Mechanical System
The wall mounted suspension system includes:
•Wall Support (4.72” width, 9.45” cm height, 3.54” cm depth)
•Extension arms 17”¾, 27”½, 35”½, and 43”¼
(45, 70, 90, and 110 cm) long

IntraOs 70 – Operator’s Manual
 
•Folding arm; useful reach of
55” (140 cm) with 17”¾
(45 cm) extension arm
65” (165 cm) with 27”½
(70 cm) extension arm
72”¾ (185 cm) with 35”½
(90 cm) extension arm
80” (205 cm) with 43”¼
(110 cm) extension arm
•The mobile version is composed of:
Mobile base: 29” (74 cm) width,
42” (107 cm) height, 24”½ (62
cm) depth
Folding Arm
2.4 Weights
•Tube-head: 14.1 lb (6.4 kg)
•Round BLD: 0.22 lb (0.1 kg)
•Rectangular BLD: 0.44 (0.2 kg)
•Folding Arm: 15.4 lb (7 kg)
•Short Extension Arm:
7.7 lb (3.5 kg)
•Medium Extension Arm:
9.3 lb (4.2 kg)
•Long Extension Arm:
11 lb (5 kg)
•Very Long Extension Arm:
12.7 lb (5.8 kg)
•Wall Support: 2.9 lb (1.3 kg)
•Mobile Base: 55.1 lb (25 kg)

IntraOs 70 – Operator’s Manual
 

2.5 AutoSet Timer
The timer is working at line
voltage of 115 V ±15%,
50/60 Hz.
Mains features are:
•Microprocessor
controlled functionality
•Zero-crossing power
switching.
•Film speed setting.
•Automatic setting of
exposure time from 60
ms to 3.2 s through object selection.
•Functionality selectable at time of installation for automatic
compensation of radiation dose variations due to line voltage
fluctuations
•Manual setting possibility of exposure time from 60 ms to 3,2 s in
18 steps. Each step represents the change of the minimum
perceptible level of blackening.
•Times are set in seconds by the operator and converted in number
of mains pulses by the microprocessor with precision of 1 pulse,
corresponding to 20 ms at 50 Hz, 16.6 ms at 60 Hz.
AutoSet exposure times in s
0.06 0.08 0.10 0.12 0.16 0.20
0.25 0.32 0.40 0.50 0.64 0.80
1.0 1.25 1.60 2.0 2.5 3.2
•Child (small) or adult (large) patient selection
•Low dose setting for use of digital sensors
•Hand-switch is provided with 10 ft/3 m coiled cord.
A special installation kit is optionally available for remote
installation (33 ft/10 m cable)
•Timer can be remotely mounted.
•Overall size: 6” (15 cm) width, 9”½ (24 cm) height, 3”½ (9 cm)
depth

IntraOs 70 – Operator’s Manual
 
3. OPERATING INSTRUCTIONS
3.1 Demonstration
In order to use of the system for demonstration purposes
radiation emission has to be inhibited by disconnecting the
supply cables to the tube-head into the wall support or into
the timer.
Cables to be disconnected are those leaving the connection block
towards the tube-head (“out” connections on the connecting block).
Make sure that the disconnected cables are properly insulated to
prevent undesired contacts with live points. Use a spare block to keep
them apart.
This has to be done by trained personnel only to avoid the risk of
electrical shock.
3.2 Beam Limiting Device
The system is supplied with a
Beam Limiting Device which
grants a Source Skin
Distance of 8.27 inches
(21 cm) and has a round
output field of 2.35 inches
(6 cm) diameter.
A version with rectangular
output section of 1.38 x 1.81
inches (3.5 x 4.6 cm) is
optionally available.
This device is suitable for
either bisecting or paralleling radiographic techniques once
conveniently angled by rotating it around the vertical and the
horizontal axis.
The tube-head is free to rotate in the horizontal plane (around the
vertical axis) and can be rotated plus or minus 135° in the vertical
plane (around the horizontal axis) to set the desired angle.
3.3 AutoSet Timer
Before using the timer make sure that the proper film speed
combination and length of the beam limiting device have been
properly set into the memory of the timer.

IntraOs 70 – Operator’s Manual
 

Index 0.32 0.40 0.50 0.64 0.80 1.00 1.25 1.60 2.00
Speed E type D type

D type: Kodak Ultraspeed, Agfa Dentus M2 - E type: Kodak Ektaspeed Plus
The timer offers the possibility to correct the exposure time to
compensate radiation dose changes due to fluctuations of the line
voltage supply, thus granting consistent film blackening. This
functionality can be enabled or disabled at time of installation with a
dedicated switch (refer to the Service & Installation Manual). When
this functionality is enabled, the user is given the possibility to display
the actual exposure time after compensation instead of the one
requested.
To set the desired working parameters follow the instructions reported
here below.
•Enter the set-up menu by switching on the unit while pressing at
the same time, and for 2 s, the three keys , , and . The film
speed selection modality is thus entered.
Film Speed. The number on the display represents the index of
the speed of the film currently selected (see table above). Press
the or keys to change the
value. Press the key to exit
input mode (back to normal
operation) or the key to pass
to next selection.
Beam Limiting Device. The
number on the display either
“20” or “30” represents the
length of the BLD in cm. Press
the or keys to change the
value. Press the key to exit
input mode (back to normal
operation) or the key to pass
to next selection.
Actual Exposure Time. The
message on the display, either “on” or “OFF”, tells whether the
actual compensated time or the selected one will be displayed.
Press the or keys to change the value. Press the key to
exit input mode (back to normal operation) or the key to go
back to first selection.

IntraOs 70 – Operator’s Manual
 
To operate the systems switch the timer “on” with the button below the
unit.
During start-up all the lamps in the panel and the segments of the
display, but the yellow light of X-ray On , are blinking for 3 s, to let
the operator check that lights in the panel are properly working.
Then the same are switched off all together and the green lamp will
eventually light to indicate System Ready.
Default parameters after installation are: D type film, 20 cm BLD,
Adult patient, Upper Premolar (i.e. 0.80 s). Then last parameters used
before switching the system off will be proposed at next switch on.
Select the type of patient (child or adult ), and tooth type:
•Upper or lower incisor
•Upper or lower canine /premolar
•Upper or lower molar
•Inter-proximal bite-wing on molar/premolar
In case of use of a low-dose digital receptor press the relevant key
to reduce the radiation level.
Should you like to change the pre-set exposure value press the plus
key to increase the exposure time or the minus key to decrease
it. This brings into the manual mode of operation.
The full range of selectable times is of 18 values from 60 ms to 3.2 s.
Range of Selectable Times in s for the AutoSet Timer
.06 .08 .1 .12 .16 .2 .25 .32 .4 .5 .64 .8 1 1.25 1.6 2 2.5 3.2
Each step changes the radiation energy of a perceptible level of
blackening on the film.
Every 3 steps upward the energy is doubled, every 3 steps downward
the energy is halved.
If the functionality to compensate for the effects of fluctuations of the
line voltage is activated, the actual exposure time will be shorter (when
the line voltage - and kVp consequently - are over the nominal level)
or longer (when the line voltage - and kVp consequently - are below
the nominal level). This function is intended to grant blackening
consistency (less retakes), i.e. the correct X-ray radiation energy as
needed for the exposure.

IntraOs 70 – Operator’s Manual
 

During the exposure the yellow lamp of X-ray On , on the timer and
on the hand-switch, lights and the internal buzzer sounds to indicate
radiation emission.
As additional safety feature the timer is provided of an independent
back-up device (back-up timer and back-up relay) which is going to
cut-off radiation in case of failure of the main timer.
Alarm conditions which may occur are signalled by the lights and
display messages on the control panel as reported in Appendix D.
In case the buzzers does not quit the sound when the yellow light turns
off a fatal conditions to the output relay has occurred.
MANDATORY TO SWITCH-OFF THE SYSTEM USING
THE LINE VOLTAGE SWITCH BELOW THE UNIT.
STOP USING THE SYSTEM AND CALL TECHNICAL
SERVICE TO FIX THE PROBLEM.
The timer implements the dead-man functionality with which radiation
emission is stopped if the operator terminates the exposure by
releasing the push-button before the requested exposure time has
elapsed. An alarm is generated in this condition.
After the exposure the timer takes into account the cool-down period
and prevents an immediate exposure which would exceed the energy
allowed by the duty cycle.
During the cool-down time the digits of the selected time on the
display keep flashing and operation of the system is inhibited. Once
cooled down the digits on the disply become steady and the system is
ready again.

IntraOs 70 – Operator’s Manual
 
1
2
3
4
5
6
7
LINE
-
SWITCH
ON/OFF
EXPOSURE
HAND-SWITCH
CONNECTION
EXPOSURE
PUSHBUTTON
YELLOW
LIGHT
EXPOSURE
HAND-SWITCH
CABLE
3.4 Operation
Turn on the line voltage supply
switch on (below the timer) to
bring the system ready
Position the image receptor
where needed and orientate the
BLD accordingly.
Select the desired exposure time (using the keys or the knob
depending on the type of timer connected).
Take the exposure switch and move to a
convenient position as far form the patient
as possible.
Press the exposure pushbutton. The
exposure yellow light and the buzzer
indicate X-ray emission.
Keep the exposure pushbutton pressed until the
yellow light is switched off to indicate the end of
the exposure.
Hook back the exposure hand-switch and
process the image receptor.
Warning: If the exposure pushbutton is
released before the end of the requested
time, the radiation emission is terminated
and an alarm is generated.

IntraOs 70 – Operator’s Manual
 

3.5 Safety
•Electrical.
Trained and qualified technicians only are authorized to
remove covers and have access to power circuits.
Power supply lines must comply with safety legislation and
have ground terminals for protective earth connection.
Switch the equipment off and possibly disconnect it from line
voltage supply before cleaning or disinfecting the unit.
•Mechanical.
Make sure that fingers or other parts of the patient or of the
operator are not pinched during positioning and parking of the
equipment.
•Explosion.
The equipment cannot be used in presence of flammable gases
or vapours.
•Radiation.
Trained and qualified personnel only are authorized to operate
the equipment always complying with existing law for
Radiation Protection.
Make sure that the equipment is not left unattended.
•Environmental.
The equipment contains components which must be disposed-
of following existing law.
3.6 Cleaning
Always disconnect the line voltage supply before cleaning the unit.
Use a mild soap to remove finger or other dirty marks paying attention
not to have liquid substances enter into the equipment.
Plastic covers can be wiped with a soft cloth and light detergent.
Avoid the use solvents or corrosive detergents which can
damage painted surfaces and plastic covers.

IntraOs 70 – Operator’s Manual
 
3.7 Disinfecting
Parts which can come in touch with the patient must be cleaned
with a detergent (such as 2% solution of ammonia) and then
disinfected making sure not to use solvents or corrosive
disinfectants which can cause cracks on the plastic covers.
3.8 Functional Check
After installation the following check is recommended.
•Switch-on line voltage supply switch (below the unit) and check
that the green lamp of System Ready lights.
•Select any exposure time and position the tube-head so that
radiation is directed away without endangering anybody.
•Take the hand-switch, move as far as possible from the unit, press
the hand-switch and check that the yellow lamp X-ray on lights
and the buzzer sounds during the exposure.
•Select the longest exposure time (3.2 s), press the hand-switch,
release it before the selected time is expired and check that the
exposure is terminated immediately. An alarm condition is
generated due to early termination. Do acknowledge and reset.
•Verify that the tube-head stay in the desired position and if
necessary perform the following adjustments:
Adjust the friction for rotation around the horizontal axis.
Adjust the tension of the spring in the arm.
Fine tune the positioning of the wall support.
Refer to Service & Installation Manual for instructions.
4. DISPOSING OF OBSOLETE EQUIPMENT
The IntraOs 70 system is made of different materials which include
may kinds of metals, iron, aluminium, lead, copper and others, plastic
materials, electronic components and dielectric oil in the tube-head.
Once the system is put out of service such components
cannot be abandoned in the environment. They have to be
delivered to specialized companies for recycling or disposing
of correctly with separate collection.

IntraOs 70 – Operator’s Manual
 

Appendix A
System Components
Article
System Component
Type Code
Catalogue Number
Wall Support 93 100 11000
Extension Arm 45 cm 93 100 17100
Extension Arm 70 cm 93 100 17200
Extension Arm 90 cm 93 100 17300
Extension Arm 110 cm 93 100 17400
Folding Arm 93 100 12010
Tube Head G 120 V 93 200 01300
20 cm Round BLD 91 300 00020
20 cm Rectangular BLD 91 300 00040
AutoSet Timer 115 VAC 93 300 60200
Mobile Base 93 100 20080
Wall Plate 86 100 11500

IntraOs 70 – Operator’s Manual
 
Appendix B
Icons
IEC Type B
Equipment
Compliance to
European Community
Requirements
X-ray On
Compliance to
Canadian and US
Standards
Examine Annexed
Documentation
Line voltage supply
On - System Ready
Increase Exposure
Time (one step)
Off (Disconnected
from Line voltage
Supply)
Decrease Exposure
Time (one step)
On (Connected to Line
voltage Supply)
Child – Small Patient
~
Alternate Current
Adult – Large patient
Fuse
Upper Incisor
Protective Earth
Upper Canine/Premolar
N
Neutral Point (for
equipment permanent
connected to line)
Upper Molar
L
Live Point (for
equipment permanent
connected to line)
Lower Incisor
Inherent FIltration
Lower Canine/Premolar



Focal Spot
Lower Molar
Fragile,
Handle With Care
Bite Wing -
Interproximal
Fear of Humidity
Digital Receptor
Up
Do Not Overturn
Radiography Push
Button
Stacking Limit
4
Ionizing radiation
Separate Collection,
Do Not Dispose

IntraOs 70 – Operator’s Manual
 

Appendix C
Exposure Table
IntraOs 70 - 70 kVp, 7 mA - Exposure Times in s
D Film
E Film
Digital
Small
Patient
D Film
E Film
Digital
Focus-Film Distance 23 cm
D Film
E Film
Digital
Large
Patient
3,20
2,50
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
2,50
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
2,00
2,60
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
Upper Molar
1,60
1,25
1,00
0,80
0
,64
0,50
0,40
0,32
0,25
0,20
0,16
Upper
Premolar
/Canine
Lower
Molar
1,25
1,00
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
Bite Wing
Lower
Premolar
/Canine
1,00
0,80
0,64
0,50
0,40
0,3
2
0,25
0,20
0,16
0,12
0,10
Upper
Incisor
Lower
Incisor
0,80
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
0,08
0,64
0,50
0,40
0,32
0,25
0,20
0,16
0,12
0,10
0,08
0,06
D Film
E Film
Digital
Small
Patient
D Film
E Film
Digital
Focus-Film Distance 33 cm
D Film
E Film
Digital
Large
Patient

IntraOs 70 – Operator’s Manual
 
Appendix D
Alarm Conditions
AutoSet Timer Alarm Conditions
Code Fault /Error Signal Action Reset
A 01 X-ray requested
during cool-down
period
Green lamp
(System Ready)
flashing
System
inhibited
By acknowledgement
on the panel or when
system cooled down
A 02 Line voltage
below lower limit
Green lamp (System
Ready) and red lamp
(Alarm) flashing
System
inhibited
Automatically when
line voltage back in
range
A 03 Line voltage
above upper limit
Green lamp (System
Ready) and red lamp
(Alarm) flashing
System
inhibited
Automatically when
line voltage back in
range
A 04 Corrected
exposure time
lower than 60 ms
Green lamp (System
Ready) and red lamp
(Alarm) flashing
0.06 s
forced.
By acknowledgement
on the panel
A 05 Corrected
exposure time
greater than 3.2 s
Green lamp (System
Ready) and red lamp
(Alarm) flashing
3.2 s
forced.
By acknowledgement
on the panel
A 06 Line Frequency
Detection Failure
System Ready (green)
lamp and Alarm (red)
lamp flashing
System
inhibited
By switching system
off and on again
A 07 Exposure push
button pressed at
power on
Red lamp
(Alarm) flashing
Exposure
inhibited.
By acknowledgement
on the panel
A 08 Exposure stopped
by the operator
Red lamp
(Alarm) flashing
System
inhibited
By acknowledgement
on the panel or after
1 m
A 09 Exposure stopped
by the back-up
timer
Red lamp (Alarm)
switched on
System
inhibited
By switching system
off and on again
A 10 Back-up relay
failure
Red lamp (Alarm)
switched on
System
inhibited
By switching system
off and on again
A 11 Power switching
device failure
Red lamp (Alarm)
switched on
System
inhibited
By switching system
off and on again
A12 Line dips during
exposure
Red lamp (Alarm)
switched on
Exposure
inhibited
By acknowledgement
on the panel