Novus Installation Manual r2 0612

CRANEX Novus
Installation and Set-up Manual
Number 200410 rev. 2 (0612)
EN
Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

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Approved: Rantala Olli 11.01.07 17:33:57
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See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 30.10.08 10:42:51 A
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CRANEX Novus
Installation and Set-up Manual
Medical Device Directive

93/42/EEC
Cranex Installation and Set-up Manual

Number 200410 Ver. 2 (0612)
(D500670 rev. 2)
Original approved English language version
Soredex
P.O.Box 148
04301 Tuusula, FINLAND
Tel. +358 (0)45 7882 2000
Fax +358 9 701 5261
Installation and set-up manual 200410 I

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Soredex endeavours to produce product documentation that is accurate and
up to date. However, our policy of continual product development may result in
changes to products that are not reflected in the product documentation.
Therefore, this document should not be regarded as an infallible guide to
current product specifications. Soredex maintains the right to make changes
and alterations without prior notice.
II Installation and set-up manual 200410

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Contents
1. Introduction ................................................................................... 1
1.1 Introduction .............................................................................................. 1
1.2 Associated documentation ....................................................................... 1
1.3 Warnings and precautions ........................................................................ 2
During installation ................................................................................... 2
During unit operation .............................................................................. 2
1.4 Unit description ........................................................................................ 3
2. Pre-installation requirements ...................................................... 4

2.1 The Unit ................................................................................................... 4
2.2 The PC .................................................................................................... 6
2.3 The dental imaging software .................................................................... 6
2.4 Space requirements ................................................................................. 6
2.5 Unit dimensions ....................................................................................... 7
2.6 Fixing hardware and Installation and setup tools ....................................... 8
Fixing hardware ..................................................................................... 8
Installation tools ...................................................................................... 8
Setup tools ............................................................................................. 8
3. Installing the unit ........................................................................... 9
3.1 Preparing the unit for installation ............................................................... 9
3.2 Attaching the unit to the wall .....................................................................11
3.3 Connecting the unit to the power supply .................................................. 14
3.4 Preparing the PC ................................................................................... 15
3.5 Configuring the communication link to the PC ......................................... 16
Using an IP address ............................................................................. 16
Using Direct Connection (Medium Access Control address) ................. 18
3.6 Installing a remote exposure warning light (optional) ............................... 19
Installation and set-up manual 200410 III

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4. Checking the alignment ............................................................. 20
4.1 The Service Assistant Utility ................................................................... 20
4.2 Checking the Positions of the CCD sensor/Collimator ............................ 22
4.3 Checking the alignment .......................................................................... 24
5. Adjusting the alignment ............................................................. 26

5.1 Checking and Adjusting the Center of Rotation ....................................... 26
Checking the position of the collimator ................................................. 26
Adjusting the position of the collimator .................................................. 28
Adjusting the position of the Rotation Unit ............................................. 29
5.2 Checking and Aligning the CCD Sensor/Collimator ................................ 30
5.3 Checking and Adjusting the Chin Support ............................................... 32
5.4 Calibrating the CCD sensor ................................................................... 34
5.5 Completing the Installation...................................................................... 36
Appendix A. Technical Information ............................................ A-1
A.1 Technical specifications ........................................................................ A-1
A.2 Unit dimensions .................................................................................... A-7
A.3 Symbols that appear on the unit ............................................................ A-8
A.4 Electromagnetic declaration ............................................................... A-10
IV Installation and set-up manual 200410

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CRANEX Novus 1. Introduction
1. Introduction
1.1 Introduction
This manual explains how to install and set up the
CRANEX Novus digital panoramic dental x-ray
unit.
You will need to operate the unit during the

alignment checking procedure. Make sure that you
know how to operate the unit before starting this
procedure.
It is also essential that person installing and setting

up the unit should have attended manufacturer's
service training course.
1.2 Associated documentation

The Cranex Novus User's manual.
The Cranex Novus Service manual.
Digora for Windows 2.5 rev 1 (or above) User's

manual, or the user's manual for the dental imaging
software that will be used with the unit.
Digora for Windows 2.5 rev 1 (or above) Installation,

configuration and administration manual, or the
installation manual for the dental imaging software
that will be used with the unit.
Installation and set-up manual 200410 1

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1. Introduction CRANEX Novus
1.3 Warnings and precautions

During installation
When installing the unit always observe local and
national safety regulation concerning the installation
and use of dental x-ray equipment.
Failure to install the unit in an approved location

according to these installation instructions may
cause the device to be dangerous to both patient
and operator.
The aperture plate in the collimator is made of lead

(Pb) which is a toxic material. Do not touch it with
your bare hands.
Be careful when working on the unit when the covers

have been removed. Some mechanical parts have
sharp edges that can cause injuries if mishandled.
Some electric components are high voltage and can
be lethal if touched. Whenever possible disconnect
the unit from the main power supply when working
on it with the covers off.
If the CRANEX Novus is to be used with a 3rd party

imaging application software, not produced by
SOREDEX, the 3rd party imaging software must
comply with all applicable local laws and regulations
on patient information software. This includes, for
example, the Medical Device Directive 93/42/EEC
and / or the FDA.
During unit operation

Read and familiarize yourself with the warnings and
precautions in the User's Manual.
When checking the alignment of the radiation beam

take all necessary steps to protect yourself from
radiation.
After the unit has been installed and set up, advise
the people who will operate the unit to familiarize
themselves with the warnings and precautions in the
User's Manual.
2 Installation and set-up manual 200410

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CRANEX Novus 1. Introduction
1.4 Unit description

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2. Pre-installation requirements CRANEX Novus
2. Pre-installation requirements
2.1 The Unit
The fully assembled unit weighs 100 kg (220 lb).
Make sure that the floor where the unit is to be
installed can support this weight.
The unit must be permanently attached to a wall or

to the show stand (pt. no. 9802666).
If the unit is to be permanently attached to a wall

make sure that the wall and the fixing hardware to
be used to attach the unit to the wall can withstand a
continuous pull-out force of at least 300 kg (660 lb).
The fixing hardware (NOT SUPPLIED) to be used to

permanently attach the unit to the wall must be the
correct type for the wall and wall material. The
MINIMUM diameter of the fixing hardware is 8 mm
(5/16 in).
If the wall is made of thin material, you may have to

use a reinforcing plate on the rear side of the wall to
hold the fixing hardware.
If the area where the unit is to be installed is subject

to earthquakes, and the unit is to be permanently
attach to the wall, the base of the column must also
be permanently attached to the floor. The fixing
hardware (NOT SUPPLIED) to be used must be the
correct type for the floor and floor material. The
MINIMUM diameter of the fixing hardware is 8 mm
(5/16 in).

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CRANEX Novus 2. Pre-installation requirements
The place where the unit is to be installed and the
position from where the user will take exposures
must be correctly shielded from the radiation that is
generated when the unit is operated.
Since radiation safety requirements vary from coun-
try to country and state to state it is the responsibility
of the installer to ensure that all safety regulations
are met.
Do not install the unit in environments where there

are corrosive or explosive vapours.
Special precautions regarding EMC need to be

taken when installing the unit. For more information
refer to the EMC declaration and requirements in
Appendix A. Technical Information in this
manual.
The unit must be installed at least 1.5m (5 ft) away

from any non-medical electrical or electro-
mechanical equipment.
The unit must be connected to its own dedicated

power supply, 230 VAC or 115 VAC ±10%
depending on the voltage rating on the type label.
Extension cables MUST NOT be used with the unit.
During operation some surfaces may become hot.

When working on the unit take suitable precautions
to avoid burning yourself.
The unit is supplied in one box. The dimensions are:
Length Width Height

187 cm 76 cm 98 cm
74 in 30 in 39 in

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2.2 The PC
The PC to be used with the unit must be installed in
a location that meets all local and national safety
requirements with regards the connection of a PC to
an x-ray device.
The connection of the unit to the PC must meet

EN60601-1 requirements.
The use of ACCESSORY equipment not complying
with the equivalent safety requirements of this equip-
ment may lead to a reduced level of safety of the
resulting system. Consideration relating to the
choice shall include:
- use of the accessory in the PATIENT VICINITY
- evidence that the safety certification of the
ACCESSORY has been performed in accord-
ance to the appropriate IEC 601-1 and/or IEC
601-1-1 harmonized national standard.
2.3 The dental imaging software

The dental imaging software installed in the PC that
is used to with the unit must be MDD approved, for
example Digora for Windows (not in USA).
2.4 Space requirements

When installing the unit make sure that:
- there is enough space at the front and sides of
the unit to allow patients to enter and exit the unit
easily. Patients in wheelchairs will require more
space than standing patients.
- the unit is positioned at least 1.5m (5 ft) away

from any non-medical electrical or electro-
mechanical equipment.
- the unit is positioned so that the operator, when

protected from radiation, can see and hear the
patient during an exposure.

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CRANEX Novus 2. Pre-installation requirements
2.5 Unit dimensions

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2.6 Fixing hardware and Installation and setup tools

The following tools and hardware are required to
install and set up the unit.
NOTE: THESE ARE NOT INCLUDED IN THE
DELIVERY OF THE UNIT, UNLESS OTHERWISE
STATED.
Fixing hardware
Two (four if you plan to attach the base of the column
to the floor), sets of 8 mm (5/16 in) diameter, fixing
hardware.
The type and length of hardware will depend on the
type of wall and wall material (and floor and floor
material) to which the unit is to be attached.
NOTE
Fixing hardware is not required if the show stand (pt.
no. 9802666) is used.
Installation tools
- Electric drill
- Spanners (wrenches) 7, 10, 17mm.
- Allen keys (Hexagon socket wrenches) 1.5 -
8mm, including a 12 cm long (min) 3 mm allen
key
- Flat blade screwdriver
- Torx screwdrivers T20, T25, T30
- Spirit level
- Pliers and wire cutters
- Scissors/Knife
- Transportation wheels (part number 200830)
Setup tools
- Beam alignment tool (part number 6904590)
- Ball phantom (part number 6904580)
- Calibration filter (part number 6904270)
- Prüfkörper digital test tool for countries where
this test is required.

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CRANEX Novus 3. Installating the unit
3. Installing the unit

3.1 Preparing the unit for installation
NOTE
Save the packaging materials as they may be
needed if you move the unit to a new location.
1. Transport the box to the location where the unit

is to be installed.
2. Remove the straps that hold the box to the

pallet.
3. Lift off the top of the box and then the sides.

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3. Installing the unit CRANEX Novus
4. Remove all the accessories, the accessory box
and as much packaging material as possible.
NOTE:
DO NOT remove the packaging material that
protects the upper shelf and the rotating unit.
5. Fold down the side of the box at the hinged

column end and then slide the unit over the edge
of the pallet so that you can access the
underside of the hinged column section.
6. Turn the hinged column section down so that it is

horizontal, and then secure it in position with the
two screws supplied (M10 x 16). The fixing
holes are on the underside of the column.
Also tighten the two screws (M10 x 16) on the

sides of the column, that serve as pivots for the
hinged column section.

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7. Attach the transportation wheels to the base of
the column with two screws (M10 x 16) supplied.
8. Lift the top of the column and slide the packing

piece that supported it underneath so that you
can access the underside of the column.
Attach the two connecting rods to the two

screws at the top rear of the column.
Attach the wall bracket to the connecting rods

with the washers and nuts.
3.2 Attaching the unit to the wall

1. CAUTION - HEAVY OBJECT
A minimum of two persons are required for
the following task.
Wheel the unit to the place where it is to be
installed and lift it in position against the wall.
Make sure that the column is as vertical as
possible.

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2. Drill two fixing holes into the wall, the size must
be suitable for the fixing hardware being used,
and then attach the unit to the wall with the
appropriate fixing hardware.
3. Remove the packaging material that protects

the rotating unit and vertical carriage.
4. Place a spirit level, lengthwise, on the upper

shelf, and level the unit in the forwards/
backwards direction.
Adjustments can be made by moving the the
base of the column backwards or forwards.
5. When the unit is level in the forwards/backwards

direction, place the spirit level widthwise, on the
upper shelf, and level the unit in the left/right
direction.
Large adjustments can be made by moving the
the base of the column to the left or to the right,
and small adjustments by loosening the wall bar
fastenings and moving the top of the column to
the left or the right to level the unit.
When the unit is level tighten all the nuts and
check once more that the unit is level. Readjust
if necessary.
NOTE:
If the unit is being used in an area subject to
earthquakes, secure the base of the column to
the floor with suitable fixing hardware.

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6. Attach the covers to the bottom of the column.
A. Attach the Front Cover to the to the front of

the column with the long screws (4), they are
inserted from the rear. Do not tighten them yet.
B. Attach the Side Covers to the sides of the

column. Note that the front edge of the Side
Covers is positioned between the column and
the Front Cover and the rear edge is attached to
the back of the column with two screws.
Tighten all the screws.

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3.3 Connecting the unit to the power supply

The units are manufactured for EITHER 230 VAC or
115 VAC mains voltage. The voltage setting CAN-
NOT be modified in the field.
The unit must be connected to its own dedicated

power supply, 230 VAC or 115 VAC ±10%
depending on the voltage rating on the type label.
Extension cables MUST NOT be used with the unit.
1. Before connecting the power supply to the unit

make sure that the voltage of the power supply
is the same as that of the unit.
The voltage rating of the unit can be found on the
type label at the back of the column.
The voltage is either:
- 230 VAC ±10% or
- 115 VAC ±10%.
Also make sure that the power supply is fitted

with a 10 A (230 VAC) or a 20A (115 VAC) slow
blow fuse.
The power supply must also be equipped with
circuit breaker.
2. Connect the power supply cable from the x-ray

unit to the power supply.
Observe any national and local requirements
with regards the connection of dental x-ray
equipment to a power supply.
IMPORTANT NOTE
If x-ray unit is ever moved to a new location
CHECK that the voltage at the new location is
the same to the mains voltage which appears on
the unit type label.

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3.4 Preparing the PC

1 Position the PC to be used with the unit at least
1.5m (5 ft) away from the unit.
NOTE:
If the unit and PC are to be part of a dental
system make sure that all the other system
components and devices are installed,
connected and configured correctly. Refer to the
documentation supplied with the other
components and devices for information on how
to do this.
2. Switch the PC on and install DfW 2.5 or the

dental imaging software that will be used with
the device.
For information on how to do this refer to the
installation/configuration manual supplied with
the dental imaging software you are installing.
IMPORTANT NOTE:
During the installation when the Select
Features window appears, make sure that you
select the CRANEX Novus option.

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3.5 Configuring the communication link to the PC

There are two ways of configuring the
communication link between the Unit and the PC,
using an IP address and using a Media Access
Control (MAC) address.
Using an IP address
1. Connect one end of the Ethernet cable to the
unit (the connector at the rear of the column) and
the other end to the PC or the network.
IMPORTANT NOTE:
If you are connecting to a PC you will require a
cross connect cable.
If you are connecting to a network you will
reguire a direct connect cable.
2. UNIT: Switch the Unit on. It will carry out a self

test. When the PC light on the Unit control panel
turns RED it indicates that the Unit is
functioning, but the communication link to the
PC is not yet configured.
3. PC: Start the PC and then open DfW or the

dental imaging software that you installed.
4. In DFW select Options and then CRANEX

Novus Setup.
The CRANEX Novus Setup window will
appear.
Select the Settings page.

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5. In the Scanner Connection section, click the
IP based radio button, if it is not already
selected, and then click the Enable changing
IP address check box to activate the IP-
address field.
For stand-alone configurations you may use the
default IP address of the Unit (194.9.227.251).
Set the IP address of the PC to 194.9.227.250.
If required different addresses can be used.
NOTE:
If the the Unit is part of a network, you will have
to get an IP address for the unit from you local IP
administrator.
6. UNIT: Press and briefly hold down the TMJ key

and the T key simultaneously.
7. PC: You must now press the Send to

Scanner… button within 45 seconds of
pressing the TMJ and T keys.
8. UNIT: The unit will automatically reboot and

connect to the PC within 15-25 seconds. The
PC light will turn green, which indicates that the
connection has been successful.

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Using Direct Connection

(Medium Access Control address)
1. From the Options menu select the CRANEX
Novus Setup and then the Settings page.
2. In the Scanner Connection section, click the

Direct Connection radio button and then key in
the complete Novus Serial Number (it is on the
type label) into the Scanner serial number
field.
V60001
Select the correct NIC from the Computer

network connection drop down list.
NOTE:
If there is more than one NIC in the PC make
sure that you select the correct one.
Click OK to save the settings.
3. The unit will automatically connect to the PC

within 5-15 seconds. The PC light will turn
green, which indicates that the connection has
been successful.

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3.6 Installing a remote exposure warning light (optional)

CAUTION:
Only used a remote exposure warning light supplied
or recommended by SOREDEX.
The warning light assembly must be positioned

outside the room in which the unit is used in the
location where it can be clearly seen.
The warning light cable must be connected to the

connector at the rear of the unit
For further information on how to install the remote

exposure warning light, refer to the instructions
supplied with the light.

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4. Checking the aligment CRANEX Novus
4. Checking the alignment

4.1 The Service Assistant Utility
The Service Assistant Utility includes a number of
functions that allow the unit to be set up and
configured during installation and tested during
service and maintenance.
NOTE:
A full description of all the Service Assistant
functions can be found in the CRANEX Novus
Service Manual
To open the CRANEX Service Assistant:
1. Switch the unit and PC on and then open Digora

for Windows.
2. Press Alt + Ctrl + Shift + T to open the Digora

Service Assistant.
A warning will appear, click OK.
The Digora Service Assistant window will
appear.
In the field at the bottom of the Digora Service
Assistant window key in s (case sensitive).
>s
Press the Enter key.

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CRANEX Novus 4. Checking the aligment
3. The Cranex Novus service terminal will
appear.
In the field at the bottom of the Cranex Novus
service terminal key in help (lower case).
>help
A list of functions will appear.
-------------------------------------------------------------------------------------------------------
CMD DESCRIPTION (* available also in normal mode)
calib calibrates generator references and preheat
conf display summary of configuration data
crc configure crc check enable
dap set dose area product [<value>]
dc takes dark current image
endu endurance test, drives rotating unit 75 rounds
exp exposure (<time>) in milliseconds, default is 1000
expcnt exposure counter, use [<reset>] option to clear it
help display info on command (‘help [cmd]’ or ‘h [cmd]’)
ip configure ip address
kv set default kV [<60> <70>]
log service log [<all> <clear> <newest> <statistics>]
logsign make a service signature for current events
mac print mac address
patt generates test pattern from CCD module
prog set default program [<pan> <ped> <tmj> <test>]
quit quit service terminal
reset software reset
restore restore factory configuration
serno configure serial number (and MAC accordingly)
status retrieves status and updates clock*
still still image exposure
warmup tubehead warmup before first use
-------------------------------------------------------------------------------------------------------
To select a function, for example exp, key in exp

in the field at the bottom of the Cranex Novus
service terminal. If the fuction requires a value
or option, key in a space and then the
appropriate value or option, for example with
exp, the exposure duration can be entered.
>exp 5000
Press the Enter key.

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4. The chosen function will appear at the bottom of
the list list of functions. This indicates that it has
been selected.
5. To exit the Cranex Novus service terminal,

key in quit.
>quit
Then press the Enter key.
4.2 Checking the Positions of the CCD sensor/Collimator

1. Switch the unit and PC on if they are not already
on. Make sure that the PC light on the unit
display is green.
2. Open DfW (or the digital imaging software you

are using).
3. From the Cranex Novus service terminal

select the still (exposure, no rotation, CCD
sensor active) function.
4. Tape the calibration filter to the filtration label

that is attached to the tubehead cover.
The filter should be positioned vertically in the
center of the filtration label.

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5. Protect yourself from radiation.
Press and hold down the exposure button to
take an exposure.
7. The image should show a vertical black line (the

beam) in the middle of a vertical light gray area
(the CCD aperture). Both the beam (black line)
and the CCD aperture (light gray area) must be
vertical and the bottom edge of the beam (black
line) must be between 0.1 and 2mm from the
bottom edge of the image.
NOTE: If there is not enough contrast to see the

beam clearly, use the the retreive last image
feature to retrieve the image and then adjust the
contrast with the contrast tools. Refer to the
CRANEX Novus User's Manual, section 6, for
information on how to do this.
CORRECT:
If the beam (black line) is in the correct position
take a ball phantom exposure to check the
alignment of the unit, see section 4.3 Checking
the alignment.
INCORRECT: If the Beam (black line) does not

appear correctly in the center of the CCD
aperture (light gray area) or the beam or CCD
aperature are not vertical, the unit must be
realigned, see 5. Adjusting the alignment.

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4.3 Checking the alignment

1. Switch the unit and PC on if they are not already
on. Make sure that the PC light on the unit
display is green.
2. Open DfW (or the digital imaging software you

are using).
3. Attach the ball phantom to the chin support.
4. Set the unit to take an adult panoramic

exposure.
Refer to the unit user's manual for information on
how to do this.

Press and hold down the exposure to take an
exposure.
6. Examine the image on the display.

Two pairs of balls should be visible. The pairs
should be symmetrical and in the center of the
image. The balls should be round and the
distances between each pair of balls should be
58 ±2 mm.

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CORRECT:
If the ball phantom image is correct, then the unit
is correctly aligned and the procedures in
section 5.4 Calibrating the CCD sensor and
then 5.5 Completing the Installation should
be carried out.
INCORRECT:
If the distances between each pair of balls is
greater that 60 mm or less than 56 mm
or the pairs of balls are not symmetrical or in the

center of the image,
the unit must be realigned 5. Adjusting the

alignment.

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5. Adjusting the aligment CRANEX Novus
5. Adjusting the alignment

5.1 Checking and Adjusting the Center of Rotation
The centre of rotation is correct when the beam
strikes the "O-line" on the beam alignment tool when
the tube head is positioned first on the left-hand side
of the the beam alignment tool and then on the right.
Checking the position of the collimator

1. Drive the unit up as far as it will go so that you
will be able to see the beam alignment tool from
beneath the tubehead.

select the exp (exposure, no rotation, CCD
sensor not active) function.
3. Slide the beam alignment tool into the chin

support so that it is pointing away from the
column.
4. Manually rotate the Rotating Unit so that it is

parallel to the front of the upper shelf and the
tubehead is on the left.

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CRANEX Novus 5. Adjusting the aligment
Darken the room and then position yourself
behind and below the tubehead.
Press and hold down the exposure switch.
The x-ray beam can be seen on the beam
alignment tool.
After the exposure mark the position of the
beam with the cursor.
6. Manually rotate the Rotating Unit 180º so that it

is parallel to the front of the upper shelf and the
tubehead is on the right.

The x-ray beam can be seen on the beam
alignment tool.
Compare this beam position (tubehead on the

right) with the previous beam position (tubehead
on the left).
The distance between the two beam positions
indicates how much the collimator must be
adjusted to get the beams to coincide.

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Adjusting the position of the collimator

8. Remove the Tubehead Cover (4 screws) from in
front of the Collimator.
9. Loosen the nuts (2) that hold the collimator

assembly in position and the adjust the left/right
position of the collimator with the screw (1) on
the right-hand side.
10. Recheck the position of the beam (steps 4 - 7)

and readjust the position of the collimator until
the beam strikes the same point on the beam
alignment tool when the tubehead is positioned
on the left and then on the right.

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Adjusting the position of the Rotation Unit

11. Pull the Front Panel from the Upper Shelf and
then remove the screws (2) that hold the Top
Cover Plate in position, and slide it off.
12. Loosen the two nuts that hold the Rotation

Bearing in place. Turn the adjusting screw to
adjust the position of the the Rotating Unit.
Counter clockwise will move the Rotating Unit
towards the column and clockwise away from it.
One turn of the screw will move the Rotating Unit
approximately 2 mm.
Rotation bearing
13. Recheck the position of the beam (step 7) and

readjust the position of the Rotation Bearing
until the beam strikes the "O-line" on the beam
alignment tool.
Tighten the screws and replace all the covers.
14. Exit the Cranex Novus service terminal.

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5.2 Checking and Aligning the CCD Sensor/Collimator

1. Carry out the check described in 4.2 Checking
the Positions of the CCD sensor/Collimator.
The beam (the black line) must strike the middle
of the CCD aperture (the gray area).
If the beam (black line) is not in the middle of the

CCD aperture (the gray area), the position of
the CCD Sensor must be adjusted to the right or
left.
NOTE:
If you cannot see the beam (black line) on the
image, tape the beam alignment tool to the
sensor and visually check the position of the
beam.
If the beam (black line) is vertical, but the CCD

aperture (gray area) is not, then the verticality of
the CCD sensor must be adjusted.
If the beam (black line) is in the center of the

CCD aperture (gray area) but it is too high or
low, then the position of the Collimator must be
adjusted up or down.
NOTE:
If you adjust the position of the collimator the
center of rotation MUST be rechecked. See 5.1
Checking and Adjusting the Center of
Rotation.
If the beam (black line) is not vertical then the

verticality of the Collimator must be adjusted.
NOTE:
If you adjust the position of the collimator the
center of rotation MUST be rechecked. See 5.1
Checking and Adjusting the Center of
Rotation.

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2. To adjust the position of the CCD sensor,
remove the Aperture Cover (5 screws) from in
front of the CCD Sensor.
3. Remove the EMC shield (4 screws) from in front

of the CCD Sensor.
4. Loosen the nuts (4) that hold the CCD sensor in

place and then adjust its position with the
screws (2) on the left-hand side.
Adjust and recheck the position of the CCD

sensor until the beam is vertical and centered in
the middle of the active area of the CCD sensor.
IMPOTANT NOTE:
If you have to adjust the position of the
Collimator, see section Adjusting the position
of the Collimator, page 28, then you MUST
recheck and if necessary readjust the center of
rotation, see section 5.1 Checking and
Adjusting the Center of Rotation.
5. Tighten all the nuts and replace the cover and

then check the position of the chin rest (next
section).

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5.3 Checking and Adjusting the Chin Support

The Chin Support is in the correct positioned when
the beam strikes the "M" line on the beam alignment
tool when the rotating unit is parallel to the upper
shelf.
1. Drive the unit up as far as it will go so that you

will be able to see the beam alignment tool from
beneath the tubehead.

select the exp (exposure, no rotation, CCD
sensor not active) function.
3. Slide the beam alignment tool into the chin

support so that it is parallel to the column.
4. Manually rotate the Rotating Unit so that it is

parallel to the sides of the upper shelf and the
tubehead is at the front.

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Darken the room and then position yourself
behind and below the tubehead.
CORRECT: If the x-ray beam strikes the "M-

line" on the beam alignment tool, the Chin
Support is in the correct position. The CCD
Sensor must now be calibrated, see section 5.4
Calibrating the CCD Sensor.
INCORRECT: If the x-ray beam does not strike

the "M-line" the position of the Chin Support
must be adjusted.
6. Remove the beam alignment tool.
7. Remove the Chin Support Holder (1 screw

accessable from the underside of the patient
support handle).

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Set screw 8. Loosen the set screw that hold the Lower Shelf
Screw (the horizontal screw) in position and turn
it to adjust the position of the Chin Support
Holder.
CAUTION
DO NOT loosen the screws (2) that attach the
Chin Rest Support to the Patient Handle.
9. Replace the previously removed parts and then

repeat steps 3-5 to check the position of the
Chin Support Holder again.
Readjust if necessary.
Replace all the parts and tighen them when the
adjustment is complete.
The alignment procedure is now complete.
5.4 Calibrating the CCD sensor

1. Open the DFW program if it is not already open.
2. From the Options drop down menu select

Cranex Novus setup.
3. The CRANEX Novus Setup window will open.

Select the Device page.

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In the Image Scanning field click the Calibrate
radio button to activate it.
4. Tape the calibration filter to the filtration label

that is attached to the tubehead cover.
The filter should be positioned vertically in the
center of the filtration label.
5. Select the Adult Pan exposure program, slide

the nasion support up as far as it will go and
remove the chin support.
6. Protect yourself from radiation, and take an

exposure.
The image should be free of any horizontal lines/

stripes. If it is not repeat the procedure.

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5.5 Completing the Installation

Check that the unit functions correctly by taking test
exposures using the different programs to verify that
the unit and PC both work correctly.
The default program selection at start up is adult

panoramic. If the user wishes to have a different
default program open the Cranex Novus service
terminal select the prog function and then select
the default program, pan (adult panoramic), ped
(child panoramic), or tmj (TMJ).
The default kV must also be changed if you change

the default from adult (70 kV) to child (60 kV), select
the kv function and then the desired kV.
Quit the Cranex Novus service terminal.

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CRANEX Novus Appendix A. Technical Information
Appendix A. Technical Information

A.1 Technical specifications
Type
CRA-1
Classification
Complies with IEC 60601-1/1995, IEC 60601-2-7/1998, IEC 60601-2-28/1993 and
IEC 60601-2-32/1994, IEC 878
UL 2601-11/2006 (for products with the UL Classification Mark) and EN 55011 stand-
ards
Conforms with the regulations of DHHS Radiation Performance Standard, 21CFR
Subchapter J.
Safety according to IEC 60601-1
Protection against electric shock - Class 1
Degree of protection - Type B applied with no conductive connection to the patient
Protection against the ingress of liquids - IPX 0
Disinfection methods:
- mild soapy water (non-abrasive)
- non-alcohol based disinfectant for the the chin rest
- disposable plastic covers for bite piece, chin rest and lip support
For use in environments where no flammable anaesthics nor flammable cleaning
agents are present
Mode of operation - continuous operation/intermittent loading
Unit description
A dental panoramic x-ray units with a high frequency switching mode x-ray generator.
The unit takes panoramic exposures.
The unit uses a CCD sensor as an image receptor.
Generator
TUBE
- KL40-0.5-70, or equivalent
FOCAL SPOT
- 0.5 mm (IEC 60336/1993)
TARGET ANGLE
- 12º
TARGET MATERIAL
- Tungsten
OPERATING TUBE POTENTIAL
- Panoramic imaging 60 and 70 kV (±5 kV)
CRANEX Novus A-1

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Appendix A. Technical Information CRANEX Novus
OPERATING TUBE CURRENT

- 7 mA (±1 mA)
NOMINAL ANODE INPUT POWER
- 490 W nominal at 70 kV, 7 mA
MAXIMUM TUBE CURRENT
- 7 mA
MAXIMUM ANODE OUTPUT POWER
- 600 W nominal nominal at 75 kV, 8 mA, 0.1 s
REFERENCE TIME PRODUCT
- 7 mAs at 60 kV, 7 mA, 1.0 s
FILTRATION
- inherent filtration minimum 0.8 mm Al at 50 kV (IEC 60522/1999)
- additional filtration 1 mm Al
- patient support attenuation equivalent less than 0.2 mm Al
- total fltration 2 mm Al at 70 kV
BEAM QUALITY
- HVL over 2.0 mm Al at 70 kV
PRIMARY PROTECTIVE SHIELDING
- minimum 0.5 mm Pb or equivalent
OUTER SHELL TEMPERATURE
- +50ºC (122ºF) maximum
DUTY CYCLE
- controlled by the software of the unit
Power requirements
INPUT VOLTAGE
- 115/230 VAC (±10%), 50/60 Hz single phase, grounded socket
LINE CURRENT
115 VAC
- long term: 1.6 A (cont) at 70 kV/7 mA, 115 VAC mains)
- momentary: 8 A at 70 kV/7 mA, 115 VAC mains)
230 VAC
- long term: 1 A (cont) at 70 kV/7 mA, 230 VAC mains)
- momentary: 5 A at 70 kV/7 mA, 230 VAC mains)
MAXIMUM LINE RESISTANCE
- 1 ohm
MAXIMUM LINE FUSING
- 10 A /16A slow at 230/115 VAC (main fuse 5 A/8 A slow in the device)
LINE SAFETY SWITCH (when required)
- Approved type, min. 10 A 250 VAC
EARTH LEAKAGE CIRCUIT BREAKER (when required)
- Approved type, min. 16 A 250 VAC, breaker activation leakage current in
accordance with local regulations.
A-2 CRANEX Novus

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Mechanical parameters
PANORAMIC
- Source to Image layer Distance (SID) 500 mm (±10 mm)
- Magnification factor 1.25
WEIGHT
- 100 kg
DIMENSIONS
- (H x W x D) 2316 x 835 x 1070 mm
VERTICAL HEIGHT OF CHIN REST
- 950 - 1750 mm (± 10 mm)
Digital image receptor (CCD)

PIXEL SIZE
- 96 microns
ACTIVE SENSOR SURFACE
- 147.5 x 6.1mm
Timer
EXPOSURE TIMES
- Normal 9.0 s (±15%)
- Child 7.5 s (±15%)
- TMJ 1.8 + 1.8 s (±15%)
SINGLE LOAD RATING
70 kV, 7 mA, 9 s, panoramic
BACK-UP TIMER
- 12 s (±15%)
Leakage technique factors

PANORAMIC
- 70 kV, 1200 mAs/h (70 kV, 7 mA, duty cycle 1:20, for example a normal
exposure per 3 minutes cool-down period)
Measurement bases
The kV is measured by monitoring differentially the current flowing through 450
Mohm, 1% feedback resistor connected between the tube anode and ground.
The mA is measured by monitoring current in the HT return line, which equals the tube
current.
CRANEX Novus A-3

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Collimator
PRIMARY SLIT
- Adult panoramic slit only. For child panoramic the exposure time is reduced
to give a reduced length image.
PRIMARY SLIT SIZE
- 0.6 x 38 mm
Z-motor
DUTY-CYCLE
-Intermediate use: 6.25%, 25s ON, 400s OFF
Environmental data
OPERATING
- ambient temperature from +10ºC to +40ºC
- relative humidity 10 - 90% no condensation
STORAGE/TRANSPORTATION
- ambient temperature from -20ºC to +50ºC
- relative humidity 5 - 85% no condensation
- atmospheric pressure 500 - 1080 mbar
PC requirements
- The PC must meet the IEC 60950 standard (minimum requirements).
- Windows XP Professional, SP1 or SP2 or Windows 2000 Professional SP4
- 512 MB RAM, >20 GB HDD
- 32 MB Video RAM
- Pentium 4 or equivalent
- one Ethernet 10/100 Mbit/s NIC
- 19" CRT or 17” TFT LCD (min. resolution 1024 x 768 pixels with DfW)
System requirements and connections

- The PC and any other external device(s) connected to the system must meet
the IEC 60950 standard (minimum requirements). Devices that do not meet
the IEC 60950 standard must not be connected to the system as they may
pose a threat to operational safety.
- The PC and any other external devices must be connected in accordance
with IEC 60601-1-1.
- The x-ray unit must be connected to it’s own separate power supply. The PC
and any other external devices must NOT be connected to the same power
supply as the x-ray unit.
A-4 CRANEX Novus

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- Position the PC and any other external device at least 1.5 m (60”) from the x-
ray unit so that the patient cannot touch the PC or any other external device
while being x-rayed.
- The PC and any other external devices shall not be connected to an
extension cable.
- Multiple extension cables shall not be used.
- Do not position the PC where it could be splashed with liquids.
- Clean the PC in accordance with the manufacturer’s instructions.
X-ray system - to IEC 60601-1-1
Tube housing assembly cooling/heating characteristics
CRANEX Novus A-5

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Tube rating chart KL40-0.5-70
Anode thermal characteristics
A-6 CRANEX Novus

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A.2 Unit dimensions
CRANEX Novus A-7

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A.3 Symbols that appear on the unit
A-8 CRANEX Novus

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CRANEX Novus A-9

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A.4 Electromagnetic declaration

Guidance and manufacturer’s declaration – electromagnetic emissions
The CRA-1 is intended for use in the electromagnetic environment specified below. The
customer or the user of the CRA-1 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The CRA-1 uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class B The CRA-1 is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
Harmonic Class A connected to the public low-voltage power supply
emissions network that supplies buildings used for domestic
IEC 61000-3-2 purposes.
Voltage Complies
fluctuations/ flicker
emissions
IEC 61000-3-3
A-10 CRANEX Novus

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Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 test level Compliance level Electromagnetic
environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile.
IEC 61000-4-2 ±8 kV air ±8 kV air If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast ±2 kV for power supply ±2 kV for power Mains power quality
transients/bursts lines supply lines should be that of a
IEC 61000-4-4 ±1 kV for input/output ±1 kV for typical commercial or
lines input/output lines hospital environment.
Surge ±1 kV differential mode ±1 kV differential Mains power quality
IEC 61000-4-5 ±2 kV common mode mode should be that of a
±2 kV common typical commercial or
mode hospital environment.
Voltage dips, <5 % UT <5 % UT Mains power quality
short (>95 % dip in UT) (>95 % dip in UT) should be that of a
interruptions and for 0.5 cycle for 0.5 cycle typical commercial or
voltage variations hospital environment. If
on power supply 40 % UT 40 % UT user of the CRA-1
lines (60 % dip in UT) (60 % dip in UT) requires continued
IEC 61000-4-11 for 5 cycles for 5 cycles operation during power
mains interruptions, it is
70 % UT 70 % UT recommended that the
(30 % dip in UT) (30 % dip in UT) CRA-1 be powered from
for 25 cycles for 25 cycles an uninterruptible power
supply or a battery.
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency
(50/60 Hz) magnetic field should be
magnetic field at levels characteristic
IEC 61000-4-8 of a typical location in a
typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
CRANEX Novus A-11

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Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity IEC 60601 test Compliance Electromagnetic environment - guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to any
part of the CRA-1, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance

Conducted 3 Vrms 3V d = 1.2 P
RF 150 kHz to
IEC 61000- 80 MHz d = 1.2 P 80 MHz to 800 MHz
4-6
d = 2.3 P 800 MHz to 2.5 GHz
Radiated 3 V/m 3 V/m
where P is the maximum output power rating
RF 80 MHz to
of the transmitter in watts (W) according to the
IEC 61000- 2.5 GHz
transmitter manufacturer and d is the
4-3
recommended separation distance in
metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
a
survey , should be less than the compliance
b
level in each frequency range . Interference
may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the CRA-1 is used exceeds the applicable
RF compliance level above, the CRA-1 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting
of relocating the CRA-1.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
A-12 CRANEX Novus

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Recommended separation distances between portable and mobile RF communications

equipment and the CRA-1.
The CRA-1 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the CRA-1 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the CRA-1 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter m
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter W d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
CRANEX Novus A-13

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CRANEX Novus

Installation and Set-up Manual

Number 200410 rev. 2 (0612)

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

Medical Device Directive

Cranex Installation and Set-up Manual

Installation and set-up manual 200410 I

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

II Installation and set-up manual 200410

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

2. Pre-installation requirements ...................................................... 4

Installation and set-up manual 200410 III

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

5. Adjusting the alignment ............................................................. 26

IV Installation and set-up manual 200410

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

You will need to operate the unit during the

It is also essential that person installing and setting

1.2 Associated documentation

The Cranex Novus Service manual.

Digora for Windows 2.5 rev 1 (or above) User's

Digora for Windows 2.5 rev 1 (or above) Installation,

Installation and set-up manual 200410 1

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

1.3 Warnings and precautions

Failure to install the unit in an approved location

The aperture plate in the collimator is made of lead

Be careful when working on the unit when the covers

If the CRANEX Novus is to be used with a 3rd party

During unit operation

When checking the alignment of the radiation beam

2 Installation and set-up manual 200410

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

1.4 Unit description

Installation and set-up manual 200410 3

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

The unit must be permanently attached to a wall or

If the unit is to be permanently attached to a wall

The fixing hardware (NOT SUPPLIED) to be used to

If the wall is made of thin material, you may have to

If the area where the unit is to be installed is subject

4 Installation and set-up manual 200410

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

Do not install the unit in environments where there

Special precautions regarding EMC need to be

The unit must be installed at least 1.5m (5 ft) away

The unit must be connected to its own dedicated

During operation some surfaces may become hot.

The unit is supplied in one box. The dimensions are:

Length Width Height

Installation and set-up manual 200409 5

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

The connection of the unit to the PC must meet

2.3 The dental imaging software

2.4 Space requirements

- the unit is positioned at least 1.5m (5 ft) away

- the unit is positioned so that the operator, when

6 Installation and set-up manual 200410

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

2.5 Unit dimensions

Installation and set-up manual 200409 7

Reviewed: Koivu Jyrki Kari 11.01.07 13:10:09

2.6 Fixing hardware and Installation and setup tools