CHALLENGER Envision Anglais 03

User Manual
— Osteodensitometer —
Dual Emission X – Ray Absorptiometry

(DEXA)
Diagnostic Medical Systems
Parc de la Méditerranée - District de Montpellier - 34470 Pérols - France

Tel. : +33 467 50 49 00 - Fax : +33 467 50 49 09
CHALLENGER_Envision _Anglais_03
User Manual
— Osteodensitometer —
Dual Emission X – Ray Absorptiometry

(DEXA)
Diagnostic Medical Systems
Parc de la Méditerranée - District de Montpellier - 34470 Pérols - France

Tel. : +33 467 50 49 00 - Fax : +33 467 50 49 09
CHALLENGER_Envision _Anglais_03
CONTENTS
1 INTRODUCTION AND BACKGROUND INFORMATION.................................................3

2 USING THIS MANUAL.............................................................................................................5
3 DEVICE DESCRIPTION...........................................................................................................6
4 WARRANTY PROCEDURE......................................................................................................8
5 CLEANING..................................................................................................................................9
6 MAINTENANCE REQUIREMENTS.....................................................................................10
7 CHECK-OUT.............................................................................................................................11
8 ENVIRONMENTAL CONDITIONS THAT AFFECT USE.................................................12
9 SYMBOLS & LABELS USED.................................................................................................13
10 EQUIPMENT SUPPLIED WITH CHALLENGER AND SET-UP INSTRUCTIONS.......17
11 SYSTEM SAFETY/ CONFORMANCE TO STANDARDS..................................................28
12 DEXA PRINCIPLE...................................................................................................................31
13 T-SCORE, Z-SCORE AND REFERENCE CURVE..............................................................34
14 OPERATOR MANUAL............................................................................................................37
15 PATIENT COUNSELING INFORMATION........................................................................215
16 TROUBLE-SHOOTING.........................................................................................................219
17 GENERAL SPECIFICATIONS.............................................................................................220
18 REFERENCES / BIBLIOGRAPHY......................................................................................224
19 GLOSSARY.............................................................................................................................225
CHALLENGER_Envision _Anglais_03 1
Chapter 1 Introduction and Background Information
1 Introduction and Background Information

1.1 Device description
Challenger is an Osteodensitometer, using the technology known as DEXA (Dual Energy X-ray Absorptiometry) which itself
is controlled a standard Pentium IV 1.4 GHz (minimum), 512 RAM computer running Windows XP. It performs
measurements at various sites of the spine, the femur and the forearm using an x-ray tube and provides information on
projected area, BMD, and BMC at each measurement site.
1.2 Contraindications
Any female patients who are suspected of being pregnant should not undergo any examination, without first consulting their
personnel doctor.
1.3 Warnings
WARNING: Do not attempt to operate the equipment without first reading this manual / and receive the training from an
approved representative of DMS.
WARNING: This machine outputs a level of X-ray radiation. The applicable local and international regulations must apply
to the installation and operation of the machine.
WARNING: If the patient is or might be pregnant, contact the patient’s physician before performing an X-ray examination
WARNING: Do not look directly into the laser light
WARNING: Do not remove any paneling to obtain access to the interior of the equipment.
WARNING: Do not use portable cellular equipment (walkie-talkies, radiophones, and portable telephones) in the
proximity during operation, as this may cause an impact on the measurements.
WARNING: If the image of the patient becomes distorted, this should be considered as the machine not working correctly
and should be reacted to (refer to 16 Trouble-shooting p.219)
1.4 Cautions
CAUTION: Do not lie or sit on the machine for purposes other than scanning.
CAUTION: Remain in the room whilst performing the examination
CAUTION: Restrict the room to authorized personnel only
CAUTION: Use only accessories and peripheral devices conforming to IEC Standards.
CAUTION: Ensure that the correct voltages are set for the equipment to be connected to the mains power supply.
1.5 Adverse Effects
The quantity of examination per patient should be kept to a minimum, or in line with current European / International
Standards. No known adverse effects are known provided the limits are abided.
The public (patients) minimum recommended dosage is <1mGy/year, which is equivalent to approximately 100 examinations
in one year.
An operator must not be subjected to an average dose of more than 20mGy per year (averaged over 5 years). With an upper
limit of 50mGy in a year.
1.6 Maintaining device effectiveness
The physician / operator shall be responsible for the cleaning of CHALLENGER once a week using non abrasive cleaning
agent in order to ensure the cleanliness of the device.
Chapter 1 Introduction and Background Information
1.7 Use in specific Populations
The target population is any subject (patient) requiring an examination, with the exception of pregnant women or those
suspected of being pregnant.
1.8 Equipment supplied with CHALLENGER and set-up instructions
This manual provides a detailed breakdown of the CHALLENGER package.
1.9 System safety / Conformance to standards
The CHALLENGER system’s system safety is detailed in this manual.
1.10 Operators manual

This manual provides the operator the detailed instructions to successfully use the CHALLENGER device.
1.11 Patient counseling information

A brochure intended to make the patients better understand the CHALLENGER technology and its performance is provided in
this manual.
1.12 Contacting DMS

Can be made by telephoning the After-sale Service Department’s number: (33) 4 67.50.49.08 or faxing any document to the
04 67 50 49 09.
Chapter 2Using this manual
2 Using this manual

2.1 Information contained in this User Manual
 This handbook contains the latest information available at the time of writing.
 Changes may be periodically made to the contents of this manual. Any change will be incorporated in form of updates.
Updates to the Manual, issued between new editions, shall contain additional and/or replacement pages to be either inserted in
or attached to the original by the user.
 New editions may be released when a complete update of the manual is required.
 D.M.S. reserves the right to modify at any time the product and (or) the software described in this user’s guide.
2.2 Copyright
2.2.1 User's Manual

No part of this document may be reproduced either in whole or in part nor translated into another media or language without
prior written permission by Diagnostic Medical Systems.
© Copyright 1997 by D.M.S. - All rights reserved.
2.2.2 Software
No part of the software may be reproduced either in whole or in part nor translated into another media or language without
prior written permission by Diagnostic Medical Systems.
© Copyright 1997 by D.M.S. - All rights reserved.
The information in this document is subject to change without prior notice and does not represent a commitment on the part of
D.M.S.
2.3 Customer Feedback
D.M.S. acknowledges the importance of customer feedback and encourages users to contact D.M.S. for any suggestions or
questions about either the equipment or manual.
In case any mistake or misprint should have slipped through in this manual, please return a photocopy of the page involved to
the address below:
D.M.S.
Parc de la Méditerranée
District de Montpellier
34470 Pérols
FRANCE
Tel.: (33) 4 67.50.49.00

Fax: (33) 4 67.50.49.09
E-mail dms@dms.com
Internet web site: http://www.dms.com
Additional copies
Additional copies of this manual or other DMS literature may be obtained from the same address given above.
Chapter 3 Device Description
3 Device Description
3.1 Description of the device
Challenger is an Osteodensitometers, using the technology known as DEXA (Dual Energy X-ray Absorptiometry) which itself
is controlled a standard Pentium IV 1.4 GHz (minimum), 512 RAM computer running Windows XP.
The different examination sites are the Spine, the Femur and the Forearm. The source and the detector are moved in the X and
Y directions to obtain the analysis zones of 150x200mm and 150x150mm, and 80x80mm respectively.
The 3 sites are themselves composed into several different parts:

Spine: L2, L3, and L4
Femur: Femoral neck, (Ward’s Triangle), Trochanter, Intertrochanter.
Forearm: Ultra-distal, Mid-region, 1/3
The X-ray source emits 3 intensities, 0.1mA, 0.4mA and 0.8mA. The detector assures a count of X-rays not absorbed by the
soft tissues and thus provides the density of the measured site.
Challenger then provides the following parameters:

 BMD (Bone Mineral Density) expressed in g/cm² which represents the density of bone
 BMC (Bone Mineral Content) expressed in g which represents the dry mass of bone
These parameters are given for each area of analysis selected (either manually or automatically) on the image obtained from
the examination.
Chapter 3 Device Description
Shown below in figure, here are the photographs of the both CHALLENGER:
Figure 1 –CHALLENGER ENVISION MOBILE device
Figure 2 –CHALLENGER ENVISION STATIONARY device
Chapter 4 Warranty Procedure
4 Warranty Procedure
4.1 DMS system warranty
DMS guarantees that each product sold is free from defects (either labor or material) and shall conform to its product
specifications as defined in the user's documentation.
If the product fails to function as specified during the warranty period, it shall be repaired or replaced free of charge.
4.2 Period of warranty
The period of warranty is stated in the user's documentation.

If you install the material, warranty begins from the date of invoice.
If the material is installed by DMS, warranty begins from the date of installation.
The warranty period for products sold outside France is 12 months as from the date of installation and the date of shipment,
whichever comes first.
4.3 Limits of warranty
Misuse, accidental damage, modifications, unsuitable operating environment, unauthorized maintenance, or damage caused by
a product for which DMS cannot be held responsible may invalidate the warranty.
Items not covered by warranty
We do not guarantee:
i) Components and/or equipment which are not supplied by DMS but which constitute an integral part of the
product cannot be guaranteed by DMS.
ii) Non-DMS manufacturers or suppliers may provide their own guarantee to you.
Chapter 5 Cleaning
5 Cleaning
5.1 Cleaning Challenger
Challenger should be cleaned once a week with a soft cloth and with clean tap water in order to avoid a build-up of dust and
dirt.
NB: Cleaning of the Mattress & Cushion may be carried out using a non-abrasive cleaning agent to ensure its cleanliness.
In order to reduce the cleaning requirements on the mattress, it is worthy to consider the use of Disposable Paper Sheets,
which can be changed following each patient examination.
5.2 Cleaning the Phantom
The phantoms should be cleaned once a week with a soft cloth and with clean tap water in order to avoid a build-up of dust
and dirt.
Chapter 6 Maintenance Requirements
6 Maintenance Requirements
There are no user-serviceable parts inside. Contact your authorized service representative for any servicing required.
A Technical Manual is available on request to those personnel technically qualified and authorized by DMS to carry out
technical servicing.
6.1 Preventative Maintenance
The unit should be considered as a system during the activities of preventative maintenance, such that the unit should be
inspected, including all connecting cables, the printer and the monitor. This should include the software in that the correct
software must be used for the machine.
6.2 Customer Responsibility
This product has no particular requirements concerning the maintenance / servicing except those detailed in Chapters below.
This product and its components will perform reliably only when operated and maintained in accordance with the instructions
given in this manual.
The maintenance requirements by the user shall be limited to the tasks detailed below.
6.3 Visual Inspection
Check Challenger regularly for exterior damage, including all cables.
Do not attempt to repair or replace damaged parts. Only authorized representative of DMS may carry out any form of
maintenance or repair.
6.4 Electrical Maintenance
The User shall not be permitted to carry out any form of maintenance, other than the visual inspection that all cables are
securely positioned.
An authorized representative of DMS shall carry out all other maintenance.
6.5 Mechanical Maintenance
The User shall not be permitted to carry out any form of maintenance, other than the visual confirmation that the unit is not
damaged. Identifying any damage should be reported to the authorized representative of DMS.
An authorized representative of DMS shall carry out all other maintenance.
6.6 Compulsory Maintenance
This shall be carried out by the approved representative of DMS, and shall consist of testing the machine for its reliability /
performance, the verification of the verification and the safety of the machine. This should be carried out on a 12 monthly
basis.
Important: the average life span of the x-ray source is 5 years.
Chapter 7 Check-out
7 Check-out
7.1 Visual inspection
Check the unit regularly for exterior damage, including all cables, minimum of once per month.
Do not attempt to repair or replace damaged parts. Only qualified DMS representatives or technicians may carry out any form
of maintenance or repair.
If there is a doubt, please contact the qualified DMS representative.
Chapter 8 Environmental conditions that affect use
8 Environmental conditions that affect use

The CHALLENGER shall be operated in a dry environment using a grounded 110 V / 230 V voltage supply. All accessories
(Computer Screen, printer etc) must be connected to the CHALLENGER and not independently to the mains supply.
8.1 Operating conditions
CHALLENGER should be operated within the following conditions:

Temperature: 15° - 32°C (59° – 90° F)
Humidity: 20% - 80%
Pressure: 0.8 – 1.2 bar
8.2 Storage conditions
CHALLENGER should be stocked within the following conditions:

Temperature: 0° - 50°C (32° – 122° F)
Humidity: 20% - 80%
Failure to comply within these limits could result in inaccurate results of the examination, or in inability to carry out the
examination.
8.3 Moving the CHALLENGER
CHALLENGER is not designed to be moved over a large distance (between buildings for example) or to be submitted to hard
blows.
 Every time the CHALLENGER is moved, verification must be done.
8.4 Chair recommendations (valid only for the forearm examination)
The chair where the patient sits for a forearm examination must be positioned a certain way so as to permits accurate
measurements. A chair mounted on wheels should never be used.
Chapter 9 Symbols & Labels Used
9 Symbols & Labels Used

9.1 Symbols used on the device
Type B Equipment: classification according to the

degree of protection against electrical shock.
Earthing protection
Keep the equipment in a standing position.
Fragile, Handle with care.
Do not allow getting wet.
Approval of this unit to the European Community

Directive 93/42/EEC by Notified Body 0120
Medical Classification IIb
9.2 Symbols used in this manual
 Important note : to be read and understood
  Stop: there is a choice of options

Repeat an operation as many times as necessary
Hint / Advice for advanced learners.
! Warning
9.3 Labels used
The following labels shall be mounted onto the exterior of the Challenger.
9.3.1 Constructors Labels
Diagnostic Medical Systems - CHALLENGER
Serial Number Power
### #### 450 VA
Mains ~ Fuse Frequency

100-110V 8,0 AT / 250V 50/60 Hz
220-240V 4,0 AT / 250V
9.3.2 Warning X-ray Label
WARNING
This X-ray unit may be dangerous to patient and
operator unless the following factors are observed :
Estimated Operator Dose : 0.3m = 3.0 Gy/h
: 1.0m = NONE
Patient Dose <1Gy/h / examination
High Voltage = 86kV
CAUTION ELECTRIC SHOCK
Do not remove the protective paneling. Refer all
servicing to authorized personnel.
9.3.3 Year of Manufacture by the Manufacturer
Year of Manufacture
****
9.3.4 X-ray Warning Light Label
X-ray Warning Light

DRY CONTACT OUTPUT
50V max 1.6A max
9.3.5 Address of the Manufacturer
DMS
Par de la Méditerranée
District de Montpellier
34470 Pérols - FRANCE
Tel. 00 33 467 50 49 00
Fax. 00 33 467 50 49 09
9.3.6 Laser Warning Label
Warning Label to be found on the equipment to be supplied to Europe:
Warning Label to be found on equipment supplied to the USA:
9.3.7 Voltage Warning Label
This label is to be found on the mains supply cable going from the Mains Voltage Socket (110V or 230V) to the Machine.
They are as follows:
This machine has been set for

230V input / output
This machine has been set for

110V input / output
9.3.8 Attention, Consult accompanying documents
9.3.9 Warning of High Tension
9.3.10 Packaging Label
Environmental Storage and Transport Conditions

Temperature: -10°C to +50°C (-14°F to +117°F)
Humidity: 10% to 90% RH (no condensation)
Pressure: 700mBar – 1060mBar
Chapter 10 Equipment supplied with CHALLENGER
10 Equipment supplied with CHALLENGER and Set-up

Instructions
10.1 Equipment supplied with CHALLENGER
CHALLENGER is supplied with a complete package:
STANDARD UNIT
- CHALLENGER machine
- Power Cable
- Serial cable
- Serial adapter
STANDARD ACCESSORIES
- Arm phantom
- Fuse kit
- Spine phantom (used also for the femur)
DOCUMENTATION
- User manual
- Form “Installation card”
- Software disks in English
- Packaging list (giving details of the items being delivered)
- Customer request for Assistance Card
- Quick reference to use CHALLENGER
10.2 Scheme of the machine and accessories
10.2.1 Front view of CHALLENGER
The front view of the machine with the detail of the control panel fixed on the machine’s arm and the system display switched
on (ON) during X-ray emission (CAUTION! X-RAY) is detailed in chapter 10.6 Control panel p.21
 Mobile version:
C H A L LE N G E R
C H A L LE N G E R M U L TISITE
M U LT IS I T E
D E X A S C A N N E R
D EX A S C A N N E R
P O W ER
O K
C A U T IO N
PO W E R
X-R A Y
O K
ON
C A U T IO N
X- R AY
O N
C H A L L E N G E R
Figure 3 - Front view to the Challenger Envision Mobile
 Stationary version:
Figure 4 – Front view to the Challenger Envision Stationary
10.2.2 Rear view of CHALLENGER
Rear-view with the detail of the electrical panel connector with 9 pins for the connection to the serial port RS232 of the
computer using a serial cable socket ~11O/230 Volt for the voltage supply of Challenger master switch can be seen in chapter
10.5 Electrical connection procedures p.21
 CHALLENGER Mobile
M AI N S I N P U T IN P U T O U TP U T
V O LT A G E
S E LE C TO R
M A IN S O U T PU T 1 0 0V -1 1 0 V / 2 2 0 V - 2 4 0 V PC RE M O T E X - R A Y O N
LO C K V O LT A G E P = 1 50 V A m a xi C O M M U N I C A TI O N S I G N A L IS A T IO N L A M P
S E LE C TO R TO T A L O U T P U T -1 5 V / + 1 5 V m a x i
Figure 5 - Rear View of Challenger Envision mobile
 CHALLENGER stationary
MA I N S I NP U T IN PUT AT GE OU T P UT
S EV OL
LEC TO R
LM OC
AI NK S OU TT PA GE
S EV OL
LEC TO R
UT 1 0 0VP -1= 1 0V / 22 0m V -2ax4 0i V
T OTA15L 0 O VA
UT P U T
PC
-CO1 5 VM /M+ U 1N 5ICVA T ma
IO N xi S IGRE NMOA LI STE A TIX -RONA Y LAO MN P
Figure 6 - Rear view of Challenger Envision stationary
10.3 Unpacking CHALLENGER
CHALLENGER should be opened and unpacked by an authorized representative of DMS.
The customer for future use in case of return should keep the shipping containers and all associated hardware in store.
10.4 Set-up of CHALLENGER
 To ensure correct working conditions, you have to supply ~110 / 220 Volt at 50-60 Hz. to CHALLENGER
 The mains socket has to be earthen.
Avoid the following environment for operation or storage:

 minimum dimensions space of 3 m x 3 m ( width * depth )
 Where the equipment is exposed to water vapor.
 Where the equipment is exposed to direct sunlight.
 Where the equipment is exposed to dust.
 Where the equipment is exposed to high humidity.
 Where there is a ventilation problem.
 Where the equipment is exposed to a salty atmosphere.
10.5 Electrical connection procedures
View of the Electrical Connections found at the rear of CHALLENGER:
M A IN S IN P U T IN P U T O U TP U T
V O L TA G E
S E L E C TO R
O f O n
SC A N N E R
LO C K O U TP U T PC
V O L TA G E 1 0 0 V-1 1 0 V / 2 2 0 V-2 4 0 V R E M O TE X - R A Y O N
P = 1 5 0 V A m a xi C O M M U N IC A TIO N S IG N A L IS A TIO N L A M P
S E L E C TO R -1 5 V / + 1 5 V m a xi
TO TA L O U TP U T
Figure 7 - Electrical Connections
The following details the various connectors:
i) MACHINE LOCK – cuts the power to the machine, thus the unit can be switched on, but cannot be used. In
both positions ON and OFF the key may be removed. It is the responsibility of the User to assure the safety
of the keys. DMS do not hold any supplementary copies of these keys.
ii) INPUT VOLTAGE can be set to either 110V or 230V is included with the Master Power Switch. This
switch is also to be used to control the power to the computer.
iii) OUTPUT VOLTAGE can be also set to 110V or 230V independently for that of the power supply input.
The output supply points shall be used for the Computer and the Printer.
iv) PC COMMUNICATION : is the connection cable between the PC and the X-ray machine
v) REMOTE X-RAY SIGNALISATION LAMP: is an option for the hospital to connect up an external
warning light. For example on the outside of the room. Refer to Chapter 10.9 Installation of Supplementary
X-ray Warning Light p.24
10.6 Control panel
The control panel is positioned on top of the machine’s arm. It is composed of a number of buttons and an Emergency Switch.
The buttons are activated only in the Remote Control Mode.
The following gives details on the buttons:
i) Emergency Switch: This shall be used ONLY in an emergency; it is not to be used for switching off the machine on
an every day basis.
ii) Laser Button : Shall be used to activate and deactivated the laser light
iii) 4 x Position Control Buttons: shall be used to locate the arm of the X-ray machine into the correct position.
iv) Confirmation of Positioning of Arm: once the correct position has been obtained using the 4 x control buttons, the
position is confirmed using the OK button.
v) Release of the Arm: Is used to release the Electro-magnet to enable the Arm to fully swing away from the bed, to
enable the patient to lie easily onto the bed. The arm can then be swung back into place, and the Electro-magnet shall
be re-activated automatically.
vi) X-RAY LIGHT ON: shall light up to indicate that X-rays are being emitted.
vii) POWER SUPPLY ON: shall when lit indicate that the machine is switched on from the Master Switch – located at
the rear of the machine (See Figure 7 - Electrical Connections p.21)
C H A L LE N G E R
M U L TIS ITE
D E X A S C A N N E R P o w e r S u p p ly
E m e rg e n c y S w it c h L ig h t O N
PO W ER
C A U T IO N
X -R A Y
X-Ra y
O N
L ig h t O N
L a s e r B u tto n R e le a s e f o r A rm
4 x P o s it io n
C o n tro l B u tto n s C o n fi rm a tio n
o f P o s itio n in g o f A rm
10.7 Removal of shipping locks
W A R N IN G
Y O U W IL L D A M A G E TH E U N IT IF
Y O U D O N O T F O L L O W TH E
IN S TR U C TIO N S
A TTE N TIO N (1 ) Re m o ve s id e p a n e l
E N S U R E TR A N S P O R TA TIO N
SC R EW S A N D FO A M A R E (2 ) Re m o ve TR A N S P O R T X - R A Y F IX A TIO N B L O C K
R E M O V E D B E F O R E O P E R A TIO N
R E F E R TO U S E R M A N U A L (2 ) Re m o ve TR A N S P O R T X - R A Y F IX A TIO N B A R
A TT E N TIO N
E N S U R E TR A N S P O R TA TIO N
S C R EW S A N D F O A M A R E
R E M O V E D B E F O R E O P E R A T IO N
R E F E R TO U S ER M A N U A L
(4 ) Re m o ve th e f o a m
U n s c re w 2 s c re w s (A lle n k e y s iz e 3 ) (5 ) Re p la c e th e s id e p a n e l
PO W ER
O K
C A U TIO N
X-R AY
ON
R E M O TE X - R A Y O N
S IG N A L IS A TIO N LA M P
TR A N S P O R T X - R A Y F IX A T IO N B L O C K
TR A N S P O R T X - R A Y F IX A TIO N B A R
U n s c re w 2 s c re w s
(A lle n k e y s iz e 4 )
U n s c re w 2 s c re w s
(A lle n k e y s iz e 3 )
R e m o v e th e f o a m
Figure 8 – Challenger Mobile Transportation Locking System
Remove TRANSPORT X-
RAY FIXATION BAR
Unscrew 4 screws (Allen
key size 4)
Figure 9 - Challenger Stationary Transportation Locking System
 Ensure that the screws and foam are stored safely, in case of need for future transportation.
10.8 Electrical Connection
Challenger is connected:
1. to an earthen socket with ~110 / 230 Volt
2. to the computer with a screened serial cable
3. ensure that the Isolating Key (found at the rear of the Machine) is switch into the on position
 For the connections use ONLY the cables supplied with the device
10.9 Installation of Supplementary X-ray Warning Light
The option is provided for an external light to be automatically activated the moment that the machine commences the use of
X-rays. The installation of such a system is at the discretion of the user, but must comply with the details shown below:
It is recommended to use Low-Tension system – up to 50V.
Maximum power recommended = 80VA
! This installation should only be carried out by a Qualified Electrician

External Supply Circuit
X-Ray External Warning Light
The use of a fuse in the

network is
recommended.
BNC Male
(Isolated) Power Source
Internal Supply Circuit
X-Ray X-Ray LED mounted on

Emission the device
BNC Female Socket
Fuse 1.6 A
10.10Safety rules
For a correct use of CHALLENGER and to avoid damage to the device or to the operator please follow the instructions in this
chapter and the security rules listed below:
 Never switch off CHALLENGER while emitting x-rays

 Never remove the serial cable from CHALLENGER or from the computer while emitting X-rays.
 Don’t place objects on the mattress while scanning. The scanning results could be influenced.
 Make sure that the patient to be scanned does not wear any metallic object.
 Make sure that no object and no wall hinders the longitudinal movement of the machine’s arm.
 Make sure that the patient does not move during the scanning
 Do not move the machine from its original position without fixing first the machine’s arm with the shipment locks.
10.11Opening Up of the Bed
The bed should be opened up as follows:

i) ensure the bars on either side of the X-ray machine are slide out to the maximum
ii) fold open the bed ends, such that they lie firmly onto the 2 bars
! Do not attempt to lower the bed, until the 2 bars have been fully extended
into position. Failure to do this could damage the hinge supports.
To close up the bed, is the reverse procedure as detailed above. Note that the slide bars when fully pushed inside the body of
the machine, automatically block the two folding ends, thus holding them in place whilst under transportation.
10.12Switching on Challenger
After having connected CHALLENGER to the computer and to the mains socket, and ensured that the voltages are correctly
selected for the equipment. The equipment is ready to be switched on using the Master Switch.
To use the device, please refer to the Operator manual and to its chapters including connection, scanning and analysis.
10.13Software Installation
1. Insert the Installation CD
Figure 10 - First window
2. Click on “Next” at the bottom of the window.
3. A window titled “Choose Destination location” is then displayed as follows:
Figure 11 - "Choose Destination Location" window
4. Click on “Install” to accept the directory as default, then the program continues the installation.
Figure 12 - Software installing
5. After a few seconds, a window complete is displayed saying that the CHALLENGER software has been installed in the
computer as follows:
Figure 13 - Setup complete window
6. Click on “Finish” to complete the installation.
7. The installation of the software has been completed. Be ready to enter into the software!
Chapter 11 System Safety/ Conformance to Standards
11 System Safety/ Conformance to Standards

This section includes information about electrical safety precautions to be exercised.
11.1 Responsibility of the manufacturer
According to the Standard IEC - 601-1. The manufacturer may be held responsible for the effects on safety, reliability and
performance of the CHALLENGER only if:
 Assembly operations, setting up, adjustments, extensions, modifications or repairs are carried out by authorized people.
 The electrical system of the room in which CHALLENGER is installed complies with the requirements,
 Challenger is used in accordance with the instructions for use.
11.2 Electrical Safety Specification
CHALLENGER complies with:

 EN 60601-1 and EN60601-1-1 (General Requirements for Electrical Safety)
 EN 60601-1-2 (General Requirements for Electromagnetic Compatibility )
This product has been tested and found to be conforming to EN 60601-1-2 (Electromagnetic Compatibility). Despite this
European standard this product may cause or suffer a certain level of interference. The user should consider the following if
levels of problems are encountered:
- place a greater physical distance between the machines considered

- connect each machine to an independent power supply
! Do not use portable cellular equipment (walkie-talkies, radiophones, and portable telephones) in the proximity of Explorer
during its operation, as this may cause an impact on the measurements.
If the problem persists please contact DIAGNOSTIC MEDICAL SYSTEMS for advice or the supplier of the other products
concerned.
In order to avoid electrical shocks, do not remove the cover from the unit.
Electrical Specifications:
Line voltage (~): 100/110 V - 220/240 V

Line frequency: 50/60 Hz
Power consumption: 450 VA
IEC 601-1: Class 1
11.3 Category of Classification (according to EN 60601-1 Art.5)
 Type of protection against electric shocks for a product powered by an exterior power supply : Class I
 Degree of protection against electric shocks : Type B
 Degree of penetration of liquids : IPX1 (product is protected against the vertical fall of drops of water)
 Sterilization : not applicable
 Product is not-adapted for use in the presence of a mix of inflammable anesthetic with air or with oxygen or with nitrous
oxide
 Method of Operation : continuous service
11.4 X – Ray Radiation
This system uses an X-ray source that emits ionizing radiation in the form of X-rays. It may be dangerous to both patient and
operator if handled incorrectly. To avoid any unsafe situations do not attempt to service this equipment yourself. Always refer
to an authorized representative of DMS.
Notice Concerning Regulatory Compliance
Challenger complies with IEC 601-1-3 and IEC 601-2-7 (International Electromechanical Commission)
For details of the specification of the X-rays refer to chapter 11.5 Laser Light Radiation p.29.
It is the responsibility of the User to check the regulations concerning X-ray equipment. This may include notifying the
regulatory agency about your installation and / or operator training and certification. Please check the regulations in your
province or country.
11.5 Laser Light Radiation
This machine is equipped with a laser light to aid the operator to locate the correct position of the arm in relation to the
patient.
The label attached to the machine is detailed in chapter 9.1 Symbols used on the device p.13
! Never stare directly into laser beam.

11.6 Emergency Stop Pushbutton
The Challenger is equipped with an emergency stop push button. If this button is pushed the machine will immediately stop
and no more X-rays will be generated.
The Emergency Stop Button should be left on at all times. This button should not be used as a means to stop / start the power
on the machine.
The button should only be used in emergency situations such as:

 If the red X-ray light remains on after the scanning has been completed
 If the machine fails to act in the manner anticipated by the user.
 If there is any doubt in the machine fulfilling the procedure required, e.g. the computer freezes just before, during
or after an examination.
If this button is used, then the following procedure must take place:
i) Switch off the Master Switch found behind the machine
ii) Reset the Emergency Button
iii) Switch on the master switch
iv) Carry out an Quality Control Verification Examination, before continuing with the patient scans
NOTE: If the operator suspects a problem then they should contact immediately, their authorized representative of
DMS.
11.7 Isolating Key
This key is found at the rear of the machine, and enables the operator to close down completely the machine, cutting off the
power supply to both the machine and the computer. Thus ensuring there is no risk of any unauthorized use of the machine in
their absence.
The key should be placed in the key hole at all times, except when the machine is required to be isolated to prevent
unauthorized use.
11.8 End of Life Disposal
European Standards require that at the end of the useful life of a machine it should be disposed of in an appropriate manner.
DMS recommends disposing of this unit in accordance with the latest European Standards at that time.
If a doubt exists regarding the nature and type of components/materials used, please contact DMS prior to its disposal.
11.9 Registration
Government health departments often require medical facilities to register diagnostic x-ray equipment. Many municipal and
state health agencies require medical health facilities to employ certified radiologic technologists to operate diagnostic x-ray
devices. Contact the Department of Health office in your city, state, or country to ensure that proper guidelines for registration
and regulation compliance are being met.
Laser registration also varies from state to state. Contact the Department of Health in your city, state or country for
information about the laser registration.
11.10Facilities
Post a “Caution X-radiation” sign in the area or room where the system is operated. The system should not require additional
shielding in he walls, floor, or ceiling of the room where the system is installed. This is due to the low levels of leakage
radiation from the x-ray tube housing assembly. However consult with your state or local health and radiation safety
department regarding shielding requirements for your country.
No additional signs are required for the laser, but you may want to contact the Department of Health in your city, state or
country for possible regulations.
11.11 Personnel monitors
It is impossible that you will receive or excess the maximum permissible dose while working with a CHALLENGER bone
mineral analyzer.
However, some facilities may choose to use personnel monitors due to the surrounding environment, i.e. other x-ray machines
etc. Consult with your Radiation Safety Officer regarding your facility’s policy.
Film badges and thermal luminescent dosimeter (TLD) badges for personnel monitoring can be obtained from a supplier
accredited for personnel dosimetry processing.
The laser does not require the use of personnel monitors.
Chapter.14: Operator manual
12 DEXA Principle
12.1 General theory on the Dual Energy X-ray Absorptiometry
Dual energy X-ray Absorptiometry (DEXA) enables quantitative assessment of bone mineral in specific
regions of the body. The use of two photon energies minimizes errors that result from irregular soft body
masses and body contours.
In theory, in order to analyze a given number of substances, attenuation measurements at the same
number of discreet photon energies are required. Simultaneous equations obtained by applications of
Lambert’s law can be solved only if there are as many independent equations as unknowns. Since the
attenuation coefficient is correlated, the number of substances that can be determined is limited.
Two photon energies, therefore, allow discrimination of two substances in a given system. If only two
substances are present, the technique is capable of high accuracy. In the case where more than two
substances are present, the accuracy with which the two substances of interest can be measured depends
on the number of additional substances, their attenuation characteristics, and the fraction of total that
they represent.
Clinically, a two component system can be defined as consisting of bone mineral and soft tissue. The
equations describing the attenuation of two photons, as they pass through a bone tissue mass, are b:
IL= IOL e- (µSLMS + µBLMB)
IH – IOH e- (µSHMH + µBHMB)
Where:
IO = Unattenuated photon fluence rate (photon /sec)
I =Attenuated photon fluence rate (photon/sec)
M = Mass of given substance (g/cm²)
µ = Mass attenuation coefficient (cm²/g)
l = 40 keV
h = 65 keV
s, b = Subscripts for soft-tissue and bone
The photon energies are stated as 40 keV and 65 keV, since these are currently the most commonly used
energies for DEXA scanning. These low energy photons enable detection of very small changes in the
two component systems. The photon fluences can be measured directly and the attenuation coefficients
can be determined by various methods, the simplest being the use of published values. Only two
quantities, MS and MB, result in the following expression:
RB  Ln(IH/IOH) – Ln(IL/IOL)
MS in g/cm² =
µSL- µSH  RB
RS  Ln(IH/IOH) – Ln(IL/IOL)
MB in g/cm² =
µBL - µBH  RS
Where:
RS = µSL/µSH
RB = µBL/µBH
The R value is the ratio of soft tissue attenuation at 40keV to that at 65keV. A typical ratio is 1.35 with
higher values (1,40) in lean subjects and lower values (1,30) in obese subjects.
Approximately 60% of the weight of hydrated bone is due to bone mineral and 38% of the bone mineral
is calcium. The non-mineral components of bone include fat, collagen, and water of hydration. The
composition of the bone
Mineral is essentially invariable, while the non-mineral components of bone and the composition of
surrounding soft tissue vary considerably between individuals and over time. The data reduction
algorithm used by CHALLENGER makes corrections for the variability in the soft tissue composition.
12.2 DEXA results
The machine continuously samples the bone mineral content (BMC) as it moves in a rectilinear pattern
over the lumbar spine or other area of interest. The resulting series of transverse profiles provides the
data base fort quantitative analysis. The calculated BMC is calibrated against a set of bone simulating
standards of known bone mineral content in order to correct for systematic errors and simplify the data
processing.
The quantities measured by DEXA are:
 Area, expressed in cm², which is the two-dimensional projection of the bone;

 Bone Mineral Content (BMC), expressed in grams;
 Bone Mineral Density (BMD), expressed in grams per centimeter squared (g/cm²)
The BMD is the BMC normalized for bone size and provides the most clinical information. BMC and
Area values are provided on analysis printouts, but they are intended only for research use, not for
clinical use.
Patient movement during the examination can compromise the precision of total and regional
measurements. Thus, the patient should be encouraged to lie quietly during the entire length of the
examination.
12.2.1 AP spine
In the lumbar spine region, the BMD is usually calculated from L2 through L4, although results can be
calculated for other regions-of-interest. Results other than L2 through L4 are useful in situations where
L2, L3 or L4 cannot be analyzed due to prostheses or fractures in those vertebral regions.
The precision of the machine on the spine may be adversely affected if fewer than three vertebrae are
used in longitudinal studies or if the exact same region is not analyzed – e.g., if L1-L3 is mistaken for
L2-L4. Factors that can affect results are the anatomical variability of L1 and the presence of ribs near
L1, the pelvis around L5, and the inconsistent use of only one or two vertebrae as the region-of-interest.
Inclusion of L14 in the region-of-interest (L1 though L4) will usually decrease the mean BMD of the
region; whereas, inclusion of L5 (L2 though L5) increases the mean density, because L1 typically has a
lower BMD and L5 a higher BMD than the L2-L4 sequence.
12.2.2 Femur
In the proximal femur, the region-of- interest is usually the area 1.5 cm wide across the entire femoral
neck. Additional regions are defined by the software in the lower density Ward’s triangle region, and in
the region of the greater Trochanter. Bone loss in the proximal femur begins in the Ward’s triangle
region and proceeds outward from there. This makes the region an early indicator of bone loss, but the
higher variance in measuring it, compared to the neck region, makes the latter zone a better
discriminator.
12.2.3 Forearm
In forearm scans there are three regions-of-interest: the Ultradistal site, the Mid-region site and the 1/3
site for Ulna and Radius. Repeat determinations of regions and subregions at different times can be best
compared by reviewing the print out from previous scans to verify that the regions are comparably
located (i.e., the cuts are located similarly). Small variations in delineation of these regions have a larger
effect on the BMC than on the BMD.
13 T-score, Z-score and Reference Curve

13.1 The T-score
The T-score is defined as the difference between the patient’s value and the mean value in a population
of young healthy subjects, which are the same gender and race as the patient. “Young” means the age of
peak bone mass, typically between 20 and 40 years. This difference is expressed as a number of
standard deviations, which avoids any dependency on the parameter measured, its unit and its biological
variation. In a more mathematical expression:
value of patient  mean value in young healthy population

T  score 
s tan dard deviation in young healthy population
During childhood, bone density regularly increases until approximately 20 years and then it stabilizes
for several years. After 40 years, it will start to decrease due to normal aging. There is therefore a
maximum value, the “peak bone mass”, obtained between 20 and 40, which is used as reference value.
It represents the typical BUA value in a healthy bone. The difference between the patient’s value and
this reference value is a logical index of bone health.
However, the simple difference cannot be directly exploited, because it depends on the scale of the
parameter used. It is therefore necessary to divide it by the standard deviation in the reference
population, which measures the dispersion of the values observed in the reference population. Let’s take
an example. The reference temperature in the human body is 37°C. If a patient’s temperature is 36.8°C,
we can say that this patient is 0.2°C below the normal, but should we worry about him? To obtain the
answer, we must know that the values measured in a healthy reference population can vary from –0.5°C
to +0.5°C compared to the mean value of 37°C. If we now compare our difference: 0.2°C, to the typical
variation: 0.5°C, we understand that our patient is healthy.
By definition of the standard deviation, 95% of the normal population has a value comprised between
the mean minus two standard deviations, and the mean plus two standard deviation, which we can note:
[mean-2SD, mean+2SD]. The World Health Organization defined that osteoporosis is established when
a BMD measurement gives a value below mean –2.5SD. It is equivalent to say that osteoporosis occurs
when the T-score is inferior to –2.5. Between –1, and –2.5, one says the patient has O steopenia (i.e.
“lack of bone”). In practice, there is of course no such clear limit, and the risk of fracture progressively
increases when the T-score decreases.
13.2 The Z-score
The Z-score is defined as the difference between the patient’s value and the mean value in a population
of healthy subjects of the same age, also divided by the standard deviation. In practice, a clinical study
allows one to determine a “reference curve”, representing the measurement mean value as a function of
age in a healthy population.
For young subjects, i.e. between 20 and 40, there is no significant difference between Z-score and T-
score.
For older patients however, the bone density decreases, and it is normal to observe a decreasing of T-
score. The Z-score is then useful to determine if the low bone density of an old patient is due to the
normal decreasing of bone density with age (in this case the Z-score is close to 0), or if there is a “high -
risk” of fracture (in this case the Z-score is negative).
13.3 The reference curve
The reference curve displays the Bone Mineral Density (BMD) in function of ages, for one or all region
of interest of the study.
.
The reference curve is provided for the spine’s L2, L3, L4 vertebrae, the Femur’s Neck, Greater
Trochanter, Intertrochanter and the Forearm’s Ultradistal, Midregion and 1/3 in order to generate T-score
and Z-score values as diagnostic values.
N o rm a l
O s t e o p e n ia - 1 .0
- 2 .5
O s t e o p o ro s is
Age
T- S c o re
- 1 .0
- 2 .5
Age
14 Operator Manual
1. DAILY SEASONING AND SOFTWARE PRESENTATION................................................41
1.1. DAILY SEASONING...............................................................................................................................................41
1.2. SOFTWARE PRESENTATION...................................................................................................................................44
2. START EXAMINATION AND ANALYSIS............................................................................47
2.1. HOW TO MAKE AN ACQUISITION.........................................................................................................................47
2.2. HOW TO READ THE EXAM WINDOW....................................................................................................................80
2.3. HOW TO MODIFY AN UNSATISFACTORY ANALYSIS..............................................................................................90
2.4. MEASURE: AREA , DISTANCE AND ANGLE...........................................................................................116
3. WORKING ON AN ANALYSIS INDEPENDENTLY OF AN EXAMINATION..............123
3.1. OPENING THE “VIEW SCAN” SECTION..............................................................................................................123
3.2. DISPLAYING AN ANALYSIS AFTER SELECTION WITH PATIENT’S LAST NAME...................................................124
3.3. DISPLAYING AN ANALYSIS AFTER RESEARCH WITH EXAM TYPE OR DATE........................................................125
3.4. DISPLAYING THE PATIENT FOLLOW-UP..............................................................................................................128
3.5. PRINTING THE MEDICAL REPORT.......................................................................................................................138
3.6. PRINTING MULTI SCAN REPORT.........................................................................................................................139
3.7. PRINTING ON A DICOM SYSTEM......................................................................................................................142
4. DATA MANAGEMENT............................................................................................................145
4.1. OPENING THE DATA MANAGEMENT FILE..........................................................................................................145
4.2. HOW TO PERFORM A RESEARCH........................................................................................................................146
4.3. HOW TO MANAGE A PATIENT FILE.....................................................................................................................152
5 DAILY QUALITY CONTROL..............................................................................................163
5.1 OPENING THE QUALITY CONTROL FILE.............................................................................................................163
5.2 HOW TO CARRY OUT THE QUALITY CONTROL...................................................................................................164
5.3 HOW TO VISUALIZE PREVIOUS CONTROLS........................................................................................................169
5.4 VIEWING THE QUALITY CONTROL RESULTS.....................................................................................................170
5.5 HOW TO EXPORT A FILE....................................................................................................................................176
5.6 PRINTING THE GRAPH AND THE RESULTS OUT..................................................................................................177
5.7 QUITTING THE “QUALITY CONTROL” FILE.......................................................................................................178
6 OPTIONS.................................................................................................................................181
6.1 DATABASE.........................................................................................................................................................182
6.2 ARCHIVAGE.......................................................................................................................................................183
6.3 SCAN.................................................................................................................................................................200
6.4 LANGUAGE........................................................................................................................................................202
6.5 CALCULATION...................................................................................................................................................204
6.6 PRINT................................................................................................................................................................205
6.7 INSTITUTE INFORMATION..................................................................................................................................206
6.8 WARMUP AND QUALITY CONTROL...................................................................................................................207
6.9 E-MAIL AND DICOM.......................................................................................................................................209
6.10 CONTACT...........................................................................................................................................................210
6.11 COMMENTS........................................................................................................................................................211
6.12 MAINTENANCE..................................................................................................................................................212
7 QUITTING THE CHALLENGER PROGRAM..................................................................213
1 Daily Seasoning and software

presentation
This chapter will detail the different steps of the machine seasoning, before giving an overview of the
CHALLENGER Envision software content.
1. DAILY
SEASONING AND SOFTWARE PRESENTATION............................................................41

1.1. DAILY SEASONING...............................................................................................................................................41
1.2. Software presentation.........................................................................................................................................44
1. Daily seasoning and software presentation

1.1. Daily seasoning
! The machine must be used in specific conditions:

 The temperature room must be comprised between 18°C and 30°C
 There must be no brutal temperature variations
 There must be no humidity in the room
1. Before starting an examination, verify that the machine is ON
2. If not, turn the machine on : set the main input buttons on “1”
3. Turn the computer on.
4. Open Challenger software by double-clicking the icon on the desktop Windows screen. The following window
appears on the screen :
Figure 14 - Init Window
! Before clicking on « Perform Init », make sure that:

There is nothing on the bed
The emergency stop pushbutton is pulled out
Nothing may hinder the machine arm movement
5. Click on “Perform Init”. The machine arm positions itself at the initialization place on the left hand side of the
device. The following window appears on the screen :
Figure 15 – “Perform init” window
6. The tests begins
Figure 16 - Init test begins
Figure 17 - Test X-Ray Flow Window
7. Monoblock warm up
! Make sure there is nothing on the bed during the X-Ray shoot time !
To perform the quality control, please refer to chapter 5 Daily Quality Control p.161.
1.2. Software presentation
The main menu introduces the user to the different options available in the software: the operator/the user uses them while
making an examination or working on a patient database or analysis independently of an examination.
Figure 18 - CHALLENGER Main Menu
COMMAND BUTTONS FUNCTIONS

“Measure” To start an examination with an existing patient or with a
new patient.
To access to the Patient database (identity card, particulars
about the patients, analysis of the examination’s results)
the doctor must fill out before beginning the examination.
“Analyse” To access and / or complete previous analyses or to
analyze the results of a new examination.
“Data” To access to the examination database.
“Quality control” To daily check out the reliability of the machine’s results
on different ROI.
“Options” To access to the technical parameters for the machine used
by technical maintenance only.
“Quit” To return to the main screen.
Tableau 1
2 Start examination and Analysis
This chapter will describe the stages the user must go through in order to perform an examination, from the
examination processing to the analysis of a scanned image.
It will show the user how to fill in or open a patient database previous to a scanning session.
It will also give the different stages of an examination processing from the positioning of the patient and the
Region of Interest adjustment to the scan processing and the analysis.
T his chapter will detail the stages the user must go through in order to carry out the analysis of a
scanned image, restart an unsatisfactory operation at any stage of the analysis process, either immediately after a
examination or independently of an examination session.
2. START EXAMINATION AND ANALYSIS............................................................................47

2.1. HOW TO MAKE AN ACQUISITION.........................................................................................................................47
2.1.1. How to perform a examination with an existing patient............................................................................47
2.1.2. How to perform a examination with the last patient..................................................................................47
2.1.3. How to add a new patient..........................................................................................................................48
2.1.4. How to start examination...........................................................................................................................50
SPINE ACQUISITION...............................................................................................................................................55
FEMUR ACQUISITION.............................................................................................................................................59
FOREARM ACQUISITION........................................................................................................................................63
DUAL FEMUR ACQUISITION.................................................................................................................................67
COMBI SCAN ACQUISITION...................................................................................................................................73
2.2. HOW TO READ THE EXAM WINDOW....................................................................................................................80
2.3. HOW TO MODIFY AN UNSATISFACTORY ANALYSIS..............................................................................................90
SPINE ANALYSIS MODIFICATION.........................................................................................................................91
FEMUR ANALYSIS MODIFICATION.......................................................................................................................99
FOREARM ANALYSIS MODIFICATION................................................................................................................107
2.4. MEASURE: AREA , DISTANCE AND ANGLE...........................................................................................116
2. Start examination and Analysis

2.1. How to make an acquisition
 Click on “Start scan” on the main menu. The following window appears on the screen :
Figure 19 - Patient database in “Start Scan” menu
COMMAND BUTTONS ON THE TOP FUNCTIONS

“Last name” To find the patient file in the database with his surname
or the first letter of his surname
“Patient ID” To find the patient file with the patient ID
“Birth date” To find a patient file with the birth date
“Start scan” To start the examination
“Add a new patient” To create and store a new patient file
“Close” To close the “Start Scan” window
Tableau 2
2.1.1. How to perform a examination with an existing patient
1. Select the patient name in the list.
2. Click on “Start Scan” at the bottom left hand side of the screen. Then please follow instructions exposed in
chapter 2.1.4 How to start an examination p.50.
2.1.2. How to perform a examination with the last patient
1. Click with the right mouse button on “Start Scan” button on the main menu and choose “Start Scan with patient…”
2.1.3. How to add a new patient

1. Click on “Add a new patient”. The following window appears on the screen :
Figure 20 - Patient database in “Start scan”
COMMAND BUTTONS AT THE BOTTOM FUNCTIONS

“Start Scan” To create and store a new patient file in the database
before an examination
"Add Comment" To add some patient information.
“Close” To return to the main menu
Non active buttons Not available on this screen
Tableau 3
FIELDS FUNCTIONS
“Patient ID” Patient’s identification number
For example tax or social security code
Format : 16 characters, any type
“Last name” Name of the patient
“First name” Format : 20 characters, any type
“Birth date” Date of Birth of the patient
Format : mm / dd / yyyy or dd / mm / yy
“Sex” Format : female, male
“Ethnic group” List of the available ethnic group
“Menopause age” Age when menopause occurred for female patient
Cannot be mentioned for a male patient
“Address, City, ZIP code, Country /State” Address of the patient
Format : Address : 40 characters, any type
City : 20 characters, any type
Zip: 10 characters, any type
Country/State
“Primary Phone” Phone numbers and fax of the patient
“Secondary Phone” Format : 8 characters/16 characters, numbers only
“Fax Phone”
Tableau 4
2. Fill in the patient’s private data in the “Private Data” section:
Figure 21 - "Private data" section
 Type his / her surname, first name, birth date (month, day, year) and sex.
 Select his / her ethnic group (Caucasian, Hispanic, Asian).
 Click on the field and drag the mouse’s cursor down to the patient’s ethnic group.
 Optionally, type his /her full address, telephone number and personal code.
 Optionally, precise the menopause age (for a female patient).
3. Optionally, fill in the “Note” field with additional information about the patient (patient’s medical history, sports
practiced, etc.)
Figure 22 - Note field
  Refer to 2.2 “How to print the medical report” p.89to print the patient comment
2.1.4. How to start an examination
 STEP 1 : SITE CHOICE
1. After filling the patient’s private data part, click on “Start scan” at the bottom of the window. The following
window appears on the screen :
Figure 23 - “site chose” Window
2. Patient height and weight allow the system to determine the mode (Normal or Large) for the acquisition; indicate
the patient’s height and weight and select the site to examine in the unrolling menu as follows. :
Left forearm Right forearm Left femur Right femur Spine
Dual femur Left femur spine Right femur spine
3. Do not forget to enter the forearm length (measure from the articulation wrist to the elbow) in the forearm case.
4. Choose IntelliScan in Spine mode to reduce the time examination
5. Position the patient on the scanning table as follows :
 STEP 2: POSITIONING
 Patient positioning
1. To let the patient lay on the table more easily, set the machine’s arm on the side of the table with the buttons of the
remote control:
!The patient must be correctly positioned on the imaging table, the cushion bearing his legs and arms along the body. In the
event of a femur examination, the limbs of the patient will be surrounded by two cushions filled with rice so as to prevent the
laser light from scanning air.
The doctor shall never position the patient’s arm upon the cushions.
 Positioning the patient on the scanning table
Figure 24 - Patient position for a Spine examination
Figure 25- - Position of the patient for a left Femur examination
Figure 26 – Position of the patients' feet for a left Femur examination
Figure 27 - Position of the patient for a Forearm right examination
2. Once the patient has been positioned on the examination table, click on “YES”.
3. The machine’s arm automatically positions above the patient.
4. A window representing the remote control, appears on the screen
Figure 28 – Remote control on screen
 Positioning the laser above the region to examine
Position the laser light at the center of the beginning of the scanned area using the arrow buttons on the remote control panel
of the machine (   )
 Positioning the laser above the region to examine
 Take the time to position the laser as shown on the figure! This will save examination time.
Figure 29 - Position of the laser for a spine examination Figure 30 - Position of the laser for a femur examination
Figure 31 - Position of the laser for a forearm examination
5. Once the laser has precisely been positioned on the region to examination, click on “STOP” on the remote control
window on the screen or on “OK” on the machine‘s remote control.
 STEP 3 : ACQUISITION
SPINE ACQUISITION
1. Select Spine area by clicking on the skeleton or by selection in the district menu.
Figure 32 - Spine area selection by clicking on the skeleton
2. Then click on “Valid”.
Figure 33 - District validate
. !Before clicking on “OK”, make sure that:

 the patient is off the table
 the machine’s arm is closed
 there is nothing on the cushion
3. The auto-verification starts up: the machine should emit X-rays for about 20 seconds.
Figure 34 - Short verification step
4. If it is the first time you make a spine examination, the machine will ask you to confirm these values as references
values
Figure 35 - Recording values window
The remote control window appears on screen to activate the arm remote control. To let the patient lay on the table more
easily, set the machine’s arm on the side of the table with the buttons of the remote control:
Figure 36 - Positioning patient window
  To position the patient on the table refer to Position the patient on the scanning table as follows :p.51.
Click on valid to start the examination.
5. Once the examination is finished the window as follow appears. You can open the arm, using the keyboard button,
and let the patient go down from the table
Figure 37 – Analysis message box
COMMAND BUTTONS FUNCTION

“Save” You will save the examination and return to the main window
“Analysis” You will make the analysis just after the click
Tableau 5
Once you click on Analysis the follow window appear:
Figure 38 - Spine Analysis Window
  Refer to Chapter 2.3 How to modify an unsatisfactory analysis p.90
FEMUR ACQUISITION
This procedure will be applied as well as for right and left femur or both.
1. Select Femur area by clicking on the skeleton or by selection in the district menu.
Figure 39 - Femur area selection by clicking on the skeleton

4. If it is the first time you make a femur examination, the machine will ask you to confirm these values as references
values
Figure 43 – Validation position femur
  To position the patient on the table refer to Position the patient on the scanning table as follows :p.51.
Figure 44 - End scanning window

Tableau 6
Once you click on Analysis the follow window appears:
Figure 45 - Femur Analysis Window
FOREARM ACQUISITION
This procedure will be applied as well as for right and left Forearm.
1. Select Forearm area by clicking on the skeleton or by selection in the district menu.
Figure 46 - Forearm area selection by clicking on the skeleton
2. Write the patient Forearm length then click on “Valid”.

4. If it is the first time you make a Forearm examination, the machine will ask you to confirm these values as
references values
Figure 50 - Validation position Forearm
  To position the patient on the table refer to Position the patient on the scanning table as follows : p.51.

Tableau 7
Figure 52 - Forearm Analysis Window
DUAL FEMUR ACQUISITION
1. Select Dual Femur area by clicking on the skeleton or by selection in the district menu.
Figure 53 – Dual Femur area selection by clicking on the skeleton

4. If it is the first time you make a Femur examination, the machine will ask you to confirm these values as references
values
Figure 57 - Validation position Right Femur
5. Once the examination is finished the window as follow appears. Click on OK to start the second verification.
!Before clicking on “OK”, make sure the patient is not on the cushion !
Figure 58 - Window of alert between exams
6. The auto-verification starts up to the second exam: the machine should emit X-rays for about 20 seconds.
Figure 60 - Validation position Left Femur

Tableau 8
Figure 62 – Dual Femur Analysis Window
  To modify the Left or Right Femur, click on the wanted button and refer to Chapter 2.3 How to modify
an unsatisfactory analysis p.99
COMBI SCAN ACQUISITION
1. Select CombiScan area by clicking on the skeleton or by selection in the district menu.
Figure 63 – CombiScan with Left Femur area selection by clicking on the skeleton
Figure 64 - CombiScan with Right Femur area selection by clicking on the skeleton

4. If it is the first time you make a Femur examination, the machine will ask you to confirm these values as references
values
Figure 68 - Validation position Right Femur
5. Once the examination is finished the window as follow appears. Click on OK to start the second verification.
! Before clicking on “OK”, make sure the patient is not on the cushion !
Figure 69 - Window of alert between exams
6. The auto-verification starts up to the second exam: the machine should emit X-rays for about 20 seconds.

7. If it is the first time you make a Spine examination, the machine will ask you to confirm these values as references
values
Figure 72 - Validation position Spine

Tableau 9
Figure 74 – CombiScan Analysis Window
  To modify a Spine analysis, refer to Chapter 2.3 How to modify an unsatisfactory analysis p.90
  To modify a Femur analysis, refer to Chapter 2.3 How to modify an unsatisfactory analysis
p.99
2.2. How to read the exam window
Figure 75 - Spine analysis window
Functions available on the analysis window and for any site (Forearm, Femur, Spine):

“Patient” & “Modify Patient Data” To see and modify the patient data
“Add Analysis” To add a different ROI than L1 L2 L3 L4
“Modify Analysis” To modify ROI and Outlines data
“Zoom” To increase / decrease the displayed image
“Contrast” To change the images contrasts
“Print” To print the analysis results
“Patient follow-up” To check all the analysis of the same patient
“Display” To obtain the radiological image
“Modify ROI Label” To modify the label to the different ROI
“DICOM” To print the data on a DICOM printer
“Export” To export the analyzed data to a file on any storage
“Detail results” To obtain all the results in details
“Exam Info” To obtain the information receiving during examination.
“Close” To close the window and come back to the main menu
Non active buttons Not available
Tableau 10
 Modify the contrast
 In order to change the contrast, perform the image quality and allow a better reading, click on the moving command
with the mouse and move it as follows :
Figure 76 - Contrast adjustment
 Modify the Display
1. The doctor might want to remove the mask to obtain a quasi radiological image. Click on “Display” as follows,
Figure 77 - Choosing Display
2. A new window appears, click to “OUTLINE” to remove the mask, and click to “Standard ROI” to remove the
different ROI.
3. Validate then the picture appears as follow.
Figure 78 - Display window
Figure 79 - Mask Analysis Image
 Change the zoom
The user may use the “Zoom” function for better precision.
- Click in the unrolling field at the bottom of the window :
Figure 80 - Unrolling menu in Zoom function
Figure 82 – Zoom function X2

Figure 81 – Zoom function X1
- Position the cursor in the blue frame to move the “Zoom” window at the wanted place :
Figure 83 - Blue frame positioning
 How to read the results
It is possible for the user to consult the normality curve on the top right hand corner and the results board:
Figure 84 - Normality Curve (L2, L3, L4 average)
Figure 85 – Exam Results Table
1. Click on “Detailed results” in order to obtain the patient densitometry data. The following table appears on the
screen :
Figure 86 - Detailed Results Window
  Refer to chapter 2.2 “How to print the medical report” p.89 In order to print comments on medical report.
 How to display the patient follow-up
1. Click on “Patient follow-up” at the bottom of the window.
Figure 87– Clicking on “Patient follow-up”
2. The following window appears on the screen, displaying results and graph per exam :
Figure 88 - Patient follow-up window
3. Click on a point on the graph, the corresponding exam image appears on the left hand side of the window.
  Refer to 3.4 Displaying the patient follow-up p.128

 How to Modify ROI labels on the spine analysis
If L2, L3, L4, L5 are displayed, it is necessary to modify the label of the first ROI. Press the “Modify ROI Label” button at the
bottom of the window:
1. Clicking on “Modify ROI Label” to change the name of the ROI
Figure 89 - Clicking on “Modify ROI Label”
2. The following message appears on the screen :
Figure 90 - “Modify ROI label” message

3. Select the first ROI name in the unrolling field as follows :
Figure 91 - Selecting first ROI name
4. Click on “OK”, the ROI name appear as follow:
Figure 92 - Image before changing first ROI label

Figure 93 - Image after changing first ROI label
 How to print the medical report
1. Click on “Print” to obtain a printed report :
Figure 94 - Clicking on “Print”
2. The following window appears on the screen, displaying the printed report :
Figure 95 – Printed Report Window

“Print” To print the medical report
“Restore” To obtain the initial image size or contrast
“Zoom in” To increase the image view
“Zoom out” To decrease the image view
“Send by Email” To send the results by email
“Export” To save the examination on the hard disk (for example)
“Close” To close the medical report window
Tableau 11
3. Click on “Print” to confirm printing.
  To print Patient /Exam comments, refer to chapter 6.6, Print p.205 and select this parameter.
2.3. How to modify an unsatisfactory analysis
The practitioner might be unsatisfied by the results and the analysis image; it is possible for him to work on the examination
just after or independently of the examination session:
He will redefine the outlines and the ROI positioning before BMD recalculation. Proceed as follows for any site examinations:
1. Immediately after the examination process, click on “Modify analysis” at the bottom left hand side of the analysis
window :
Figure 96 - Clicking on “Modify analysis"
2. The analysis window appears on the screen. Please see below how to modify the analysis for each site :
Figure 97 - Analysis window

SPINE ANALYSIS MODIFICATION
 After clicking on “Modify Analysis”, the doctor should obtain an image as follows :
Figure 98 - Spine Analysis Window with poor ROI

“Patient” To display patient confidential data
“ROI” To modify ROI
“Outline” To modify the Outline
“Measurement” To obtaining any kind of measures.
“Add ROI” To add a new ROI
“Modify ROI” To modify a customize ROI
“Cancel Action” To remove a previous action.
“Delete ROI” To erase a ROI
“Fill outline” To fill in the outlines
“Contrast” To modify contrasts
“Recalc BMD” To recalculate the BMD after modifications
“Save analysis” To save the new analysis
“Cancel analysis” To cancel the new analysis
Tableau 12
o Modify the outlines
1. Click on “Outline” at the bottom left hand side of the window :
Figure 99 - « Outline » button
2. The following image appears on the screen :
Figure 100 - Outline window
3. The image appears automatically in “Mask” mode and the cursor is changed into a blue pastille.
The user may use the “Zoom” function if necessary at the bottom of the screen.
The cursor size does not change during the “Zoom” function using.
- To add some outlines, click on the left button of the mouse
Figure 101 - Before adding outlines

Figure 102 - After adding outlines
- To remove some outlines, click on the right button of the mouse
Figure 103 - Before removing outlines Figure 104 - After removing outlines
o Cancel action
Click on “Cancel action” to erase last action(s) if necessary. Click in the unrolling field and select the number of actions to
erase.
o Modify the ROI
1. Click on “ROI” at the bottom left hand side of the screen :
Figure 105 - ROI button
2. The user may work the ROI in the Normal or Mask mode : tick the box “Fill outline” in order to remove the mask
Figure 106 - Ticking the “Fill outline” Box
Figure 107 - Normal Mode Figure 108 - Mask Mode

3. Modify the ROI with the help of the mouse by clicking in the central and lateral blue frames and moving the mouse
as follows :
Figure 109– Readjusting the intervertebral line with

central blue frame
Figure 110 - Readjusting the ROI with the lateral

blue frame
The following picture is obtained, displaying the new ROI:
Figure 111 - Spine analysis picture after modification

The new results are automatically recalculated and appear in the table:
Figure 112 - Previous results Figure 113 - New results

- To save the last results, click on “save analysis”.
The following message appears on the screen:
Figure 114 – Confirmation window
Click on yes. The new results will be displayed on the analysis window.
- To come back to the former results, click on “cancel analysis”. The following message appears on the screen :
Click on Yes to cancel updates.

The analysis window appears on the screen again.
Figure 115 - Spine analysis picture with new ROI
  Refer to chapter 2.1.4 How to start an examination p.50

FEMUR ANALYSIS MODIFICATION
 The following window appears on the screen, displaying the regions of interest :
Figure 116 - Femur analysis window with poor ROI
In a similar case and considering on the following drawing how the region of interest should be placed, it is highly
recommended to the doctor to proceed to a manual positioning.
Femoral Neck ROI Trochanter ROI
Ward’s triangle ROI

Intertrochanter ROI
Figure 117 - Femur ROI

Proceed as follows:
o Modify the Outlines
1. Click on “Outline” at the bottom left hand side of the window :
Figure 118 – Outline Analysis button
2. The following image appears on the screen :
Figure 119 - Poor femur outlines

- To add some outlines, click on the left button of the mouse
- To remove some outlines, click on the right button of the mouse
Figure 120 - Rectifying femur outlines Figure 121 - After rectification

o Modify the ROI
1. Click on “ROI” at the bottom left hand side of the screen :
2. The following window appears on the screen :
Figure 123 – Poor ROI Image
3. Modify the ROI with the help of the mouse by clicking in the blue frames and moving the mouse and following the
images exposed just below. First change the baseline positioning if wrong :
 Click in the blue frame as indicated
opposite and place the baseline just
Figure 124 - Raising the baseline just below the small trochanter
below the small trochanter.
4. Modify the femoral neck ROI box, it should be perpendicular to the central axis of the femur neck
First modify the central axis of the femur neck until position it at equal distance from the femur neck edges:
Figure 125 - Rectifying the central axis of femoral neck
- Then click in the blue frame to move the femoral neck ROI and take it down until it is tengential to the greater trochanter
ridge. It should include bone of the femoral neck and soft tissue at either end of the box. Please pay attention not to include
bone from the trochanter or ischium (it may occur if the ischio-femoral angle is closed).
Greater
trochanter ridge
Ischio-femoral
angle
Figure 126 - Rectifying position of the femoral neck ROI
5. Relocate the Ward’s triangle region of interest :
 The Ward’s triangle should be placed in the base of the femoral neck, in the area of lowest bone mass. Adjusting the
ward position to find the lowest BMD ; to do that consult the BMD value at the bottom of the window :
Figure 127 – Searching lowest BMD value

6. The new results appear in the table :
Figure 129 - New results
Figure 128 - Previous results
Figure 130 – Save analysis window

- To come back to the former results, click on “Cancel analysis”. The following message appears on the screen :
Click on Yes.
  Refer to 2.1.4 How to start an examination p.50 (Femur Acquisition)

FOREARM ANALYSIS MODIFICATION
 The following window appears on the screen, displaying the regions of interest :
Figure 131 - Forearm analysis window with poor ROI
In a similar case and considering on the following drawing how the region of interest should be placed, it is highly
recommended to the doctor to proceed to an analysis modification.
Proceed as follows:
o Modify the Outlines
1. After exam acquisition, click on “Outline” at the bottom left hand side of the analysis window :
Figure 132 - Outline analysis button
2. The following window is displayed :
Figure 133 - Poor forearm outlines

- To add some outline, click on the left button of the mouse
- To remove some outline, click on the right button of the mouse
Figure 134 - Rectifying forearm

Figure 135 - After outlines rectification
outlines
o Modify the ROI
1. Click on ROI at the bottom left hand side of the screen :
Figure 137 - Poor ROI window

3. Modify the ROI with the help of the mouse by clicking in the blue frames and moving the cursor to the wanted
place :
4. First click in the blue frame at the top of the

yellow box and raise it until the extremity of the
ulna bones :
Figure 138 - Raising the frame just below the wrist

articulation
5. The yellow line shall be at the extremity of the

ulna as right:
Figure 139 - Adjusting the external box positioning

6. Then move the ultradistal box as follows, placing the green frame between the radius and ulna bones and paying
attention not to include some cortical bone (the whitest part) in the region of interest :
Cortical Bone
Figure 140 - Moving the ultradistal box
7. Next adjust the central and lateral axis as follows ; include soft tissues of the forearm in the ROI :
Figure 141 - Adjusting the central and lateral axis

8. At last the following picture is obtained :
Figure 142 - Forearm analysis picture with new ROI

9. The new results appear in the table :
Figure 143 - Previous results Figure 144 - New results
Figure 145 - Save analysis window

- To come back to the former results, click on “Cancel Analysis”. The following message appears on the screen :
Click on Yes.
  Refer to Chapter 2.1.4 How to start an examination p.50 (Forearm Acquisition)

2.4. MEASURE: AREA , DISTANCE AND ANGLE
You can have a measure of bone on any Exam Spine, Femur or Forearm
1. Click on “Modify Analysis”
Figure 146 - Femur window
2. Click on “measurement”
Figure 147 - Analysis window

3. Click on “add measurement”
Figure 148 - Clicking on "Add Measure"
4. Select “Area or Distance or Angle”
Figure 149 - Select distance measurement

5. Select a “name” ”colour” and “fill” to your measure
Figure 150 - Give a name to the measurement
6. Double click to mark the first point
Figure 151 - Double click at the first place

7. Double click to mark the second point
Figure 152 - Double click to the second point
8. Click on “Save Analysis” to save the measure
Figure 153 - Save Analysis

3 View examination
This chapter will describe the functions of the software the doctor can use independently of an examination
session. It will show how to work on a patient analysis, and how to restart an unsatisfactory analysis,
independently of an examination.
3. WORKING ON AN ANALYSIS INDEPENDENTLY OF AN EXAMINATION..............123

3.1. OPENING THE “VIEW SCAN” SECTION..............................................................................................................123
3.2. DISPLAYING AN ANALYSIS AFTER SELECTION WITH PATIENT’S LAST NAME...................................................124
3.3. DISPLAYING AN ANALYSIS AFTER RESEARCH WITH EXAM TYPE OR DATE........................................................125
3.4. DISPLAYING THE PATIENT FOLLOW-UP..............................................................................................................128
3.5. PRINTING THE MEDICAL REPORT.......................................................................................................................138
3.6. PRINTING MULTI SCAN REPORT.........................................................................................................................139
3.7. PRINTING ON A DICOM SYSTEM......................................................................................................................142
3. Working on an analysis independently of an
examination
3.1. Opening the “View Scan” Section
1. Click on “View Scan” in the main menu to open the file.
2. The following window appears on the screen, displaying the existing patients and performed examinations lists
:
Figure 154 - Existing patient list

“Last name” To search an exam with the patient last name
“Birth date” To search an exam with the patient birth date
“Patient ID” To search an exam with the identification patient number
“Search by exam” To display the exam list and search with exam
“View Scan” To display the analysis window
“Print Scan” To print selected analysis results
“Patient follow-up” To compare all results to the same district of a particular
patient
“Print Multi scan” To print three analysis of a particular patient on a same
page
“Close” To close the window and come back to the main menu
Tableau 13
3.2. Displaying an analysis after selection with Patient’s Last Name
1. Unroll the patients list and select the patient name of whom the practitioner wants to display the analysis already
performed.
2. Then click on the wanted exam in the list at the bottom of the window; it is composed of the examination type,
date and time.
3. Click on “View Scan” at the bottom of the window :
Figure 155 - Exam selection for viewing
4. The analysis window appears on the screen, displaying the exam selected in the list :
Figure 156 - Selected exam analysis window
  Refer to Chapter 2.2 How to read the exam window p.80

3.3. Displaying an analysis after research with exam type or date
1. Click on “Search by exam” at the bottom of the “View Scan” window :
Figure 157 - “Search by exams” button
2. The exam list appears on the screen :
Figure 158 - Exams list
3. The practitioner may perform a research either with exam type or with exam date :
Figure 159 - Selection bare

 Displaying an analysis after research with exam type
1. Click in the “Exam Type” field at the top left hand corner of the window
Figure 160- “Exam type” unrolling menu
The unrolling menu displays the different sites (All sites / left femur / Right femur / Right forearm / Left forearm / Spine /
paediatric Spine).
2. Select the wanted exam type with the help of the mouse. The list of all exams of this type is then displayed :
XXXX
XXXX
Figure 161 - Selection of the “Left femur” exam type for research
XXXX
XXXX
Figure 162 - Selection of “Right forearm” type for research
 Displaying an analysis after research with date
1. Fill in the fields “Scan date” at the top right hand side of the window :
XXXX
XXXX
Figure 163 - Selection of the “Scan date” for research

2. The list of the exams performed at the selected date is displayed :
3. Click on “View scan” at the bottom of the window or double-click on the wanted exam to display the analysis.
3.4. Displaying the patient follow-up
 Parameters Selection
1. Click on “Patient Follow-up” at the bottom of the “View scan” window :
XXXXXXXX
Figure 164 - Patient follow-up window
2. Select the exam region wanted in the unrolling menu at the top left hand side of the window in order to perform the
patient follow-up :
XXXXXXXXX
Figure 165 - Spine selection
3. Select the Trend type :
Figure 166 - Trend type selection

Select the Trend type. The corresponding co-ordinates will appear on the abscissa axis of the graph:
 Trend BMD selected
Figure 167 - Trend BMD type
 Trend T-Score selected
Figure 168 - Trend T-score type
 Trend Z-Score selected
Figure 169 - Trend Z-score type

4. Choose the scale unit
Figure 170 – Scale selection
Select the wanted scale, the corresponding co-ordinates will appear on the vertical axis of the graph :
 Session Scale selected
Figure 171 - Session scale
 Age scale selected
Figure 172 - Age scale

 Time scale selected
Figure 173 - Time scale
5. Select the District we want to see the follow-up of in the spine case (L1 ; L2 ; L3 ; L4 ; Selection ; total)
Figure 174 - Region selection
The corresponding graph and results board are displayed on the screen :
 L2 dictrict selected
Figure 175 - L2 District
Proceed the same way as for the other district follow-up.
 Selection region selected
Figure 176 - Spine Region Selection

 Total region selected
Figure 177 - Total Region Selection
Proceed the same way as for the other sites follow-up.

 Patient follow-up window : options
See exam
1. Click on “See exam” at the bottom left hand corner of the window
Figure 178 –“See exam” button
2. The analysis window appears on the screen :
3. Click on “Modify Analysis” at the bottom left hand side of the window.
  Refer to chapter 2.3 How to modify an unsatisfactory analysis p.90

Print the exam
1. Click on “Print exam” at the bottom left hand side window :
Figure 180 – “Print exam” button
Figure 181 – Medical report window
3. Click on “Print” on the right hand side corner of the screen.

Print the trend
1. Click on “Print trend” at the bottom left hand side of the window :
Figure 182 – “Print trend” button
2. The following window appears on the screen:
3. Select one this button “Curve” or “Pictures” or “Pictures and Curves” to print.
4. When you click on “Curve” displaying the graph and the results board according to the selected criteria :
Figure 183 – “Patient trend” report
5. Click on “print” on the top right hand side of the window.

Comment
1. Click on “Comment” at the bottom left hand side of the window :
Figure 184 – “Comment” button
Figure 185 - Comment window
3. Fill in the “Comment” part and click on “Update” at the bottom left hand side of the window.
Comments will be saved and will appear on the printed report.

3.5. Printing the medical report
1. Click on “Print exam” at the bottom of the “View Scan” window :
Figure 186 – “View Scan” window
Figure 187 – Exam report before printing
3. Click on “Print” at the bottom right hand side of the window to launch the printing.
3.6. Printing Multi scan report.
The interest of this option is to print on the same page until 3 exams for the same patient.
1. Select a patient then click on “Print Multi scan” at the bottom of the “View Scan” window:
Figure 188 – View Scan window
2. The following window appears on the screen.
Figure 189 – Exam selection window

It’s possible to select different examinations data to print. Click on “Add” button or double click on the examination
name to add them to the bottom window as the following window:
Click on “Remove” button to erase a data from the list.
The different arrow on the right side permits to change the position of the examination site on the printing paper
3. Also click on “Print report”
Figure 190 - Examination selected

4. The following window appears on the screen
Figure 191 – Printing window
5. Click on “Print” at the bottom right hand side of the window to launch the printing
3.7. Printing on a DICOM system
1. From a patient exam window, click on the “DICOM” button
Figure 192 – Patient examination window

2. The following window appears on the screen:
Figure 193 – DICOM Printing preview window
3. Click on “Print” at the bottom right hand side of the window to launch the printing.
4 Data management
This chapter will describe how performing exams or existing p patients researches, how reorganizing or
updating the patient database and the possible modifications of an unsatisfactory analysis independently of an
examination session.
4. DATA MANAGEMENT..............................................................................................................145
4.1. OPENING THE DATA MANAGEMENT FILE..........................................................................................................145
4.2. HOW TO PERFORM A RESEARCH........................................................................................................................146
4.2.1. Research data with the database..............................................................................................................147
4.2.2. Research data with the patient list...........................................................................................................147
4.2.3. Research data with the exams list............................................................................................................150
4.3. HOW TO MANAGE A PATIENT FILE.....................................................................................................................152
4.3.1. “Modify” : Modify an analysis or update patient data...........................................................................153
4.3.2. “Erase“ : Erasing a patient’s examination, analysis or file....................................................................157
4.3.3. “See”........................................................................................................................................................158
4.3.4. “Print”.....................................................................................................................................................158
4.3.5. “Add”........................................................................................................................................................159
4.Data Management
4.1. Opening the Data Management file
Once the database file has been opened (refer to chapter 2.1) the doctor can manage the patient files.
1. From the main menu, click on the “Data Management” button to open the file
2. The following window appears on the screen, displaying the patient list :
XXXXXXXX
XXXXXXXX
XXXXXXXX
XXXXXXXXX
XXXXXXXX
Figure 194 - Data management window
CHALLENGER_Envision_Anglais_03 145
4.2. How to perform a research
Please refer to the fields located on the left hand side of the window:
Figure 195 – Search by criteria window

“Database” To search data with database
“Patient ID” To search data with the Patient Identification number
“Last Name / First Name” To search data with the patient’s name
“Ethnic list” To search data with the ethnic group
“Sex” (Male, female, Female & Male) To search data with the patient’s sex
“Birth date” To select the order of search
“Date To search data with the patient’s birth date
“Mode List” To select the paediatric or normal search
“Site List” To search data with the exam type
“Date” To search data with a precise examination date
“Operator” To search data with the operator name
“Importation” To select exams stored in osteodensitometers database.
“Launch search” To launch the research after selecting the parameters
Tableau 14
4.2.1. Research data with the database
1. Click on the unrolling menu on the top of the window :
Figure 196 - “Database” unrolling menu
2. Select the database in which the user want s to find data, then launch the research by clicking on “Launch
search” at the bottom right hand side of the window :
Figure 197 - “Launch Search” button
3. The list corresponding to the selected database appears on the screen.
4.2.2. Research data with the patient list
 Research data with the patient’s name
1. Enter the patient’s name in the field “Last Name” of the search by patient part :
Figure 198 - Search by patient criteria
2. Click on “Launch search” at the bottom right hand side of the screen :
Figure 199 - “launch search” button
3. Data (Birth date, types, performed exams list and date…) of the wanted patient appear at the left hand side of
the window.
 Research data with the patient’s birth date
1. Enter the wanted birth date in the “Search by patient” part :
Figure 200 - Search by birth date
2. Click on “Launch search” at the bottom right hand side of the screen :
3. The data (Birth date, site, performed exam list and date…) of the patients born at the wanted date appear on
the left hand side of the screen.
 Research data with the patient’s sex
1. Click in the “Sex” field in the “search by patient” part :
Figure 202 - Search by sex
2. Unroll the menu and choose to get the list of all existing patients, the list of the female patients only or the
list of the male patient only.
3. Click on “Launch search” at the bottom right hand side of the window :
4. The patient data (Birth date, sites, exams performed list and date…) of male, female or all appear in the list
on the left hand side of the screen according to the request.
 Research data with the ethnic group
1. Click in the “Ethnic” field in the “search by patient” part :
Figure 204 - Search by ethnic group
2. Unroll the menu and choose to get the database with patient from the wanted ethnic group.
4. The data (Birth date, sites, performed exams list and date…) of the patient from the wanted ethnic group
appear in the list on the left hand side of the screen.
4.2.3. Research data with the exams list
 Research data with the exam site
1. Click in the field “Site” in the part “Search by exam criteria” part :
Figure 206 - Search by exam site
2. Unroll the list and select the exam site of which you want to display the results.
4. The data list of the patients who underwent those types of exam appears on the screen.
 Research data with the exam date
1. Enter the exam date in the “Search by exam criteria” part :
Figure 208 - Search by exam date
2. Click on “launch search” at the bottom right hand side of the window :
3. The list of the patients who underwent an exam at the selected date appears on the left hand side of the
screen.
 Research data with the operator name
1. Click on the “Operator” field in the “Search by exam criteria” part :
Figure 210 - Search by operator
2. Select the wanted operator name and click on “Launch search” at the bottom right hand side of the window :
3. The patient database of the selected operator appears on the left hand side of the window.
4.3. How to manage a patient file
 After performed the research, unroll the patients list, select the wanted patient or exam :
XXXXXXXX XXXXXXXX
XXXXXXXX XXXXXXXX
XXXXXXX XXXXXXX
XXXXXXXX XXXXXXXX
XXXXXXXX XXXXXXXX
Figure 212 - “Launch Search” button Figure 213 - “Launch Search” button
The functions at the bottom of the window become available:
Figure 214 - Available functions after patient selection
Figure 215 - Available functions after exam selection
4.3.1. “Modify” : Modify an analysis or update patient data
The operator will use this option in order to modify an exam or update data already stocked in a patient database (new
address, phone number, etc.)
 Modify an analysis
 Select the exam in the list of the “Data management” window (Please refer to the 4.1 chapter above). Click
on “Update” at the bottom of the window. The analysis window appears on the screen. Please follow
indications in the chapter 2.3 How to modify an unsatisfactory analysis p 59
 Modify patient data
1. Select the patient in the list of the “Database management” window (Please refer to 4.2 chapter above) :
XXXXXXXX
XXXXXXXX
XXXXXXXX
XXXXXXXXX
XXXXXXXX
Figure 216 - Data management window
2. Click on “Update” at the bottom left hand side of the window. The confidential patient data file appears on
the screen :
XXXX
XXXX
Figure 217 - Confidential data of the selected patient
3. Select the data to be modified in the field as follows :
XXXXX
XXXXX
Figure 218 - Country selection
4. Click on the “Update” Button at the bottom left hand side of the window in order to record the new data.
XXXX
XXXX
Figure 219 – “Update” Confidential data of the selected patient
4.3.2. “Erase“ : Erasing a patient’s examination, analysis or file
The doctor will use this option to delete a patient’s examination, analysis or file when he won’t have anymore
examination.
 Erasing a patient’s examination or analysis
1. Select the examination or the analysis to erase in the field.
2. Click on the “Remove” button
3. The following window is displayed on the screen :
Figure 220 - Remove Message confirmation
4. Click on “YES” to confirm.
5. The patient’s examination or analysis should definitely be cleared off.
Proceed in the same way for all the scans or analyses to erase.
 Erasing a patient’s file
First remove all the patients’ scans or analyses before erasing the pa tient’s file
1. Once all the patient’s scans have been erased, click on the “Erase” button
2. The following window is displayed on the screen :
Figure 221 - Remove message confirmation
3. Click on OK
4. The database should definitely be cleared out of all the data previously stored in it
4.3.3. “See”
The practitioner will use this option in order to view the patient’s analysis before performing updates.
4.3.4. “Print”
The doctor will use this option to print the medical report corresponding to the analysis chosen in the data list.
 To print the results out, select the wanted analysis in the patient and exam list.
Click on “Print” at the bottom of the window.
The medical report appears on the screen as follows:
Figure 222 - Medical report before printing
Click on Print again on the right hand side of the window, the results are automatically printed out.
 To print all the patient data or patient follow up, select the patient wanted in the list and click on print.
The following message appears on the screen :
Figure 223 - Printing report confirmation message
Click on “All patient exams”. The printing starts up.
4.3.5. “Add”
The doctor will use this option to add a new patient to the data list.
1. Click on “Add” at the bottom of the window. An empty patient file appears on the screen :
Figure 224 - “Add a new patient” window
2. Fill in the fields and click on “Record”. The name of the new patient is added to the list.
5 Quality control
This chapter will describe the steps to follow in order to verify the accuracy of the CHALLENGER
device and the reproducibility of the measurements already made.
An external phantom is supplied with the CHALLENGER. The values are known and stored in the
software. At the beginning of each day, the operator has to perform this test before beginning any
examination on patient. This chapter will detail how to make the acquisition of a phantom, then how to
perform an examination and how to analyze the image just scanned. It will show how to open the quality
control file, then how to fill in the data relating to the measurements to verify, and finally how to display the
graph relating to the measurements and the data themselves.
5 DAILY QUALITY CONTROL..............................................................................................163

5.1 OPENING THE QUALITY CONTROL FILE..................................................................................................163
5.2 HOW TO CARRY OUT THE QUALITY CONTROL.......................................................................................164
5.3 HOW TO VISUALIZE PREVIOUS CONTROLS.............................................................................................169
5.4 VIEWING THE QUALITY CONTROL RESULTS.........................................................................................170
5.5 HOW TO EXPORT A FILE.........................................................................................................................176
5.6 PRINTING THE GRAPH AND THE RESULTS OUT.......................................................................................177
5.7 Quitting the “Quality Control” file.......................................................................................................178
5 Daily Quality Control
5.1 Opening the quality control file
 Click on “Quality Control” in the main menu. This function displays the results of the tests on external
phantoms, with both a graphic and statistic display allowing the identification of any serious problem, as
well as the identification of any trend of gradual deviation from ideal results over a period of time.
Each point which appears on the graph corresponds with a quality control:
Figure 225 - Quality Control Window

“Start Control” To perform a quality control
“Export” To export the quality control data in a CSV or DICOM file
“View” To visualize a quality control
“Parameters” To modify the curves displaying
“Print Control” / “Print History” To print the quality control report or history
Tableau 15
5.2 How to carry out the quality control
1. Click on “Start Control” at the bottom left hand corner of the window :
Figure 226 - Start Control window
2. Remove all things laying on the bed and click on “Valid Site”.
Place the phantom correctly on the sticker
Click on start examination to perform the examination
Figure 227 - Click on "Start Control"
Place the phantom on the mask as follows:
Figure 228 - Phantom mask
Figure 229 – Spine phantom
 Only L1, L2, L3 are represented on the phantom.
 The femur and the spine are represented by one phantom
The following window appears on screen. Click on validate to start the acquisition.
Figure 230 - Click on "Validate"
The following message appears on screen to confirm the phantom using.
Figure 231 - Click on “yes” to continue the phantom examination
The phantom Examination is now finish
Figure 232 – Results window
 Click on “Validate” in order to accept the results and quit. Results are recorded when switching off the
window and will appear on the graph.
The following window appears on the screen, the last measured point appears on the graphic
Figure 233 - Quality Control Window with last control
 Click on “Close” in order to cancel and quit. The following message appears on the screen :
Click on “Yes”. The quality control data won’t be saved.
Rq: If any problem occurs during the verification, the following message appears on the screen and let choice for the
user to restart or not the quality control:
Figure 234 - Counts variation message
5.3 How to visualize previous controls
1. On the graph of the quality control window, select the wanted control by clicking on the point ; the point
becomes red and the date appears as follows :
Figure 235 - Selected control
2. Click on “View” at the bottom of the window :
3. The Quality Control window corresponding with the selected exam is displayed :
5.4 Viewing the Quality Control Results
 ROI and dates choice :
Figure 236 – Data parameters
COMMANDS on the right hand side of the window FUNCTIONS

“Value Displayed” To display the kind of values
“Control of” To display the control of the selected ROI
“Average” To display the control average in the given meantime
“Standard deviation” To display the controls standard deviation in the given
meantime
“Variation margin” To display the controls variation margin in the given
meantime
“Exam Date” To display the selected control date and time
“BMD Value” To display the selected exam BMD value
“Controls” To display the performed controls number
Tableau 16
 The “Control of” field selects the Region of Interest whose measurements are going to be analyzed.
Figure 237 - Choosing ROI site
 Precise the dates between which the measurements will be checked, to allow the user to take a closer
look at a specific time period :
!The “Start Date” will always display by default the date of the first examination, and the “End Date” will always
correspond to the date of the most recent examination.
- In the “Start Data” part, enter the starting date of the measurements
- In the “End Data” part, enter the closing date of the measurements
Figure 238 - Exam selection by date
The graph representing the measurements made between the dates selected is displayed.
 graph parameters :
1. Click on “Parameters” on the top of the windows as follows.
Figure 239 – Graphic parameters button
The following board is displayed:
Figure 240 - Parameters menu
2. The doctor can refine the graph characteristics by ticking the following parameters :
CURVES FUNCTIONS
“Display Average” Data average curve
“Display Variation margin” Variation margin curve at the control time
“Display Standard deviation” Curve of the positive and negative standard deviation at the
control time
Display markers To display the building points of the curve
Display lines To display lines that link building points together
Display limits To display allowed limits for BMD
Display time axis To display exams month per month or per exams number
Y Axis Auto range To adjust automatically the range of the Y axis
Tableau 17
Markers
Average
Variation Margin
Standard Deviation
Line
Limits
Time Axis
 Displaying the graph and the measurements selected
1. After validating the quality control and selecting eventually the graph parameters, the following window
appears on the screen, displaying the graph with the last control in addition (Compare with the Figure 225
- Quality Control Window p.163) :
Figure 241 - Quality control window after last control
The acceptable values are situated in the area delimited with the red dotted lines.
In the event of a technical problem being identified (i.e. several marks being outside of the area…, please contact
D.M.S. for assistance)
5.5 How to export a file
It is possible for the user to export the quality control data in CSV (Text format with commas fields separator) or
DICOM format (In process).
1. Click on “Export” at the bottom of the window :
2. Select CSV button to save data in a CSV file or cancel to quit. DICOM is available only if the DICOM
parameters are well configured.
3. The following box is displayed :
Figure 242 - Save box window
4. Enter the file name and click on “save” to record the data.
5.6 Printing the graph and the results out
1. To print the screen out, select “Print History” at the bottom of the window
2. The following message appears on the screen :
Figure 243 - Printing Message
3. The doctor might want to print the general report of the quality control. It is possible for him to print:
- a general report (displays the report of the current control with measurements and graph for each Region
Of Interest )
- a detailed report (Historic report of all performed controls)
- a GRIO report
4. Click on “general”. The following window appears on the screen :
Figure 244 - General report
5. Click on “Detailed”. The following window is displayed :
Total
Figure 245 - Detailed report
5.7 Quitting the “Quality Control” file
Click on “Close” in the bottom right hand corner of the quality control window.
The main menu of the software is displayed.
6 Options
The doctor will use this option to get more information on the composition of the software. Moreover this part will
enable him to consult, modify or update some functioning parameters settled by default.
6 OPTIONS....................................................................................................................................181
6.1 DATABASE..............................................................................................................................................182
6.2 ARCHIVAGE............................................................................................................................................183
6.3 Opening the “Archive scans” section...............................................................................................185
6.4 How to select an exam to archive.....................................................................................................186
6.5 How to archive an exam...................................................................................................................190
6.6 How to view or restore an archived exam........................................................................................197
6.7 SCAN......................................................................................................................................................200
6.8 LANGUAGE............................................................................................................................................202
6.9 CALCULATION........................................................................................................................................204
6.10 PRINT.....................................................................................................................................................205
6.11 INSTITUTE INFORMATION.......................................................................................................................206
6.12 WARMUP AND QUALITY CONTROL.......................................................................................................207
6.13 E-MAIL AND DICOM............................................................................................................................209
6.14 CONTACT...............................................................................................................................................210
6.15 COMMENTS............................................................................................................................................211
6.16 MAINTENANCE.......................................................................................................................................212
6 Options
1. Click on “Software configuration” in the main menu. The following window appears on the screen :
Figure 246 - Software configuration window

“Database” To select one or several databases
“Archivage” To configure the archiving activation
“Language” To select the software language
“Scan” To select the examination options
“Calculation” To select calculation zones
“Print” To select printing parameters
“Institute” To fill in and display the medical institute co-ordinates
“Warmup and Quality Control” To adjust the seasoning, full flux and quality control
intervals
“E-mail” To configure the E-mail server
“DICOM” To enter or modify the DICOM parameters
“Contact” To display manufacturer co-ordinates
“Comments” To add a default comment to each patient or exam
“Maintenance” To modify software parameters (to be performed by a
qualified technician)
“Validate” To validate selected parameters
Tableau 18
6.1 Database
1. Select “Database” in the list on the left of the screen in order to choose the database type :
Figure 247 - Database Window

“Verify Database” To verify if the database is valid
“Repair Database” To repair the database in error case
“Reconstruct Database” To reconstruct the database if work on it, is not possible
Tableau 19
2. “Export Path” configuration is use to give the directory where are stored CSV files, exams reports and the
DAX files as follow.
3. “Database Options” is use to
 Specify if the software must display only the Challenger envision exams on “Database Management” or
all exams made on different device.
 Enable or disable the automatic exams display on “Database Management”.
6.2 Archivage
1. Click on “Archivage” in the list on the left of the window as follow:
Figure 248 - Archivage Window
2. Select the minimum condition to ask to do an automatic archivage

.
Figure 249 – Archivage triggering
3. Tick off the wanted parameters to make archivage.
Figure 250 – Selecting activation parameters
In order to perform the archiving a CD/DVD Writer and NERO software (minimal version:
5.5.10) running with Windows 2000 or XP are necessary.
6.2.1 Opening the “Archive scans” section
1. From the Archivage menu, click on the “Launch archivage” button to start archivage.
2. The following window appears on the screen, displaying the patients list and performed exams :
XXXXXXXX
XXXXXXXX
XXXXXXX
XXXXXXXX
XXXXXXXX
Figure 251 - Archive examination window

“Selection” To display patient selection criteria
“Statistic” To display exams per site (in %) according to the
selection criteria
To display exams per site (in %) selected in the tree on
the left hand side of the window
To display the place occupied on the hard disc
“Archives” To display archives historic, consult, read or restore from
the media the selected exam, duplicate the media
“Launch Archive” To archive a selected exam
“Collapse/expand all” To display or not exams details
Tableau 20
6.2.2 How to select an exam to archive
The selection mode is the same as in the data management chapter.
  Refer to Chapter 4 Data Management p.143 to consult the selection mode
1. The “Archive Scans” section lets the operator choose which patient’s exam you will copy. Click on the
“Selection” tab on the right hand side of the window :
Figure 252 - Selection part
2. The user has the choice to select the patient name or exam to archive among three different criteria :
-Database
-Patient Data
-Exam data
 Click in the unrolling menu and select the wanted database if several. Then click on “launch Search” at the
bottom of the window. The list corresponding to the selected database appears on the screen :
Figure 253 - Database selection
 Click in the field, write and select the item characterizing the patient entirely or partially (last Name and/or
First Name and/or Birth date and/or sex and/or ethnic group). Click on “Launch Archive” at the bottom of the
window. The list corresponding to the selected criteria appears on the screen :
XXXXXXXXXX
Figure 254 - Selection with a patient data

Figure 255 - List corresponding to the criteria
 Click in the unrolling field and select the exam site and/or the exam date and/or the operator’s name and/or
the device of importation. Click on “launch Archive”, the list corresponding to the selected criteria appears
on the screen :
XXXXXXXXXX
XXXXXXXXXX
XXXXXXXXX
XXXXXXXXXX
XXXXXXXXXX
Figure 256 - Selection with a patient data Figure 257 - List corresponding to the criteria
Rq: in the event of an exam date selection, the operator may search an exam performed at a precised date, all exams
performed before or after one date, or all exams performed at a specific time period (Start date, Closing date):
Figure 258 – Date order selection
3. Then click in the list the patient or exam to archive as follows (Click on Ctrl to select separate exams, in
that case spine and left forearm exams are selected). Statistics part automatically appears on the right
hand side of the screen:
XXXXXXX
XXXXXXX
XXXXXX
XXXXXXX
XXXXXXX
Figure 259 - Exam selection before archiving
4. Selected exams are referred in the statistics part displaying exams per site (in %) according to the
selection criteria (Query column), exams per site (in %) selected in the list on the left hand side of the
window and the place occupied on the hard disc (different regarding the media) :
Figure 260 – Archive compression statistique
6.2.3 How to archive an exam
1. After selection (see chapter above), click on the “Launch Archive” button at the bottom of the screen.
The following message appears on the screen :
2. Then the following message appears on the screen, indicating the number of media needed to perform
the archiving (estimated according to the inserted media size) :
XXXXXXXX
XXXXXXXXX
XXXXXXXX
Figure 261 - Number of media necessary
3. Click on OK. If necessary change the description of the new media established by default :
Figure 262 - Entering the media description
4. Click on “validate”. The archive begins, the following messages are displayed :
XXXXXXXX
XXXXXXXX
XXXXXXXX
Figure 263 - Archiving beginning
XXXXXXXX
XXXXXXXX
XXXXXXXX
Figure 264 - End of archiving
5. As mentioned on the screen, DO NOT REMOVE THE MEDIA : the software is going to perform a data
verification :
XXXXXXXX
XXXXXXXX
XXXXXXXX
Figure 265 - Caution message
6. The archives verification begins :
XXXXXXXX
XXXXXXXX
XXXXXXXX
Figure 266 - Beginning of archives verification
7. At the end of the verification, the following message appears on the screen and the media is ejected :
XXXXXXXX
XXXXXXXX
8. To finish archiving the selected exams, the operator should remove and label the media with the
reference corresponding to the archiving just performed; later it will give the operator the information
required to easily retrieve a patient’s exam for viewing :
XXXXXXXX
XXXXXXXX
XXXXXXXX
Figure 267 - Caution message : label the media
Make sure to carefully hand-label your media all the more reason if the operator uses several
database media!
Convention for naming the media :
A06PC300_3_1_26/01/2006
Serial number of the Archive Media Archiving Date

device number Number
9. Click on OK. The exam is archived and the following window appears on the screen:
XXXXXXXX
XXXXXXXX
XXXXXXXX
XXXXXXXXXX
XXXXXXXXXX
Figure 268 - Screen after archiving
6.2.4 How to view or restore an archived exam
Even though an exam has been archived, the list remains on the hard disk and you can view and reanalyze it if
necessary:
 HOW TO RESTORE AN ARCHIVED EXAM FROM AN ARCHIVE MEDIA
“Restore” lets you restore exams stored on archive media to the hard disk. As you restore the exams to the hard
disk, they are deleted from the archive media.
1. On the “Archive” screen select in the unrolling menu the media containing the exam to be restored to the
hard disk as follows :
Figure 269 - List of the old archives
2. The screen will display a list of all exams available to be restored to the hard disk. Select in the list the
exam(s) to be restored and click on “Launch Restore”. The following message appears on the screen :
3. Click on yes. The following messages are displayed on the screen :
4. The
program prompts you to insert the archived media that contains the exam :
5. Insert the media, then click on OK. The following messages flash by on the screen :
6. At the end of restoring, the updated list of the corresponding media is displayed on the screen.
 HOW TO DUPLICATE AN ARCHIVE MEDIA
1. Click on the “Archives” thumb on the top right hand-side of the window. Select the archive media to be
duplicated in the unrolling menu and click on “Duplicate a media”
Figure 270 - Duplicate an archive media
2. he following messages flash by on the screen :
  Refer to chapter Data management to view or modify an archived exam
6.3 Scan
1. Select “Scan” in the list on the left of the screen in order to choose the default option scan
Figure 271 – Scan window
2. Select the examination default site:
Figure 272 – Examination default site
3. Change parameters in “Display options” to modify the exams analysis:
Figure 273 – Display option
4. Select the different ethnics to display by default
Figure 274 – Ethnics to display
5. Select NHANES to display the femur Nahnes curves.
Figure 275 – Femur NHANES
6.4 Language
1. Click on “language” in the menu, in the “configuration parameters” window as follows :
Figure 276 - Language Window
2. Select the language of the software :
Figure 277 - Selecting language window
3. Validate. All software data appear immediately in the selected language.
4. Select the Measurement system – Metric or English – as follows :
Figure 278 - Selecting Measurement System
5. Select the Date format :
Figure 279 - Selecting Date Format
6. Select the time format :
Figure 280 - Selecting Time Window
6.5 Calculation
1. Click on “Calculation” in the list on the left of the window as follows :
Figure 281 - Calculation parameters selection Window
2. Select the zone on which the Forearm calculation will be performed (Ulna, Radius or both) :
Figure 282 - Bone zone selection for forearm calcul
3. Select the ROI for calculation (Ultradistal, midradius or 1/3 zone) :
4. Select the zone for spine calculation : L1 L2 L3 L4 L5
5. Select the zone for femur calculation Neck Trochanter Intertrochanter
6. To memorise the modifications, click on “Validate” at the bottom left hand side of the window.
6.6 Print
1. Click on print. The following window appears on the screen :
Figure 283 - Print window
2. Tick off the wanted printing parameters. Click on “Validate”. The selected parameters will appear on the
printed report.
6.7 Institute information
1. Click on “Institute” on the left of the screen. The following window is displayed :
Figure 284 - Institute information window
2. Enter the institute co-ordinates in the fields intended to this end.
3. Click on “Validate”. Those data are recorded and will appear on the printed reports.
6.8 Warmup and Quality Control
1. Click on “Warm up and Quality Control” on the left of the screen. The following window appears on the
screen :
Figure 285 - Warmup and Quality Control Window
2. The practitioner may want to modify the interval between seasoning and quality control. Proceed as follows :
Figure 286 - Changing Warmup interval
Figure 287 - Changing Quality Control interval
Figure 288 - Perform a warmup
6.9 E-Mail and DICOM
1. Click on “E-Mail” on the left of the window : the following window appears on the screen :
Figure 289 - E-mail Window
2. Select and modify the E-mail parameters.
3. Click on “Validate”.
Figure 290 – DICOM parameters bare
“General”, “Push”, and “Print” are use to configured DICOM server network or DICOM system
6.10 Contact
1. Click on “Contact” on the left of the screen. A window intended to provide DMS information
Figure 291 - Contact Window
6.11 Comments
Click on “Comments” on the left of the screen. A window intended to provide DMS information
Figure 292 - Contact Window
In this window the doctor can add memorised commentary.
6.12 Maintenance
The “maintenance” file will be used mainly by qualified technicians.
 Click on “Maintenance” on the left of the window to open the file. The following window appears
asking the technician to enter his/her password :
Figure 293 - Maintenance Window with Password Field
7 Quitting the Challenger program
7 Quitting the Challenger program
1. Click on “Quit” on the right hand side of the screen.
2. A window message is displayed :
3. Click on “OK” to confirm.
The Main Screen is displayed.
Chapter 15 Patient counseling Information
15 Patient counseling Information

INFORMATION FOR PATIENTS
YOU, BONE ASSESSMENT and OSTEOPOROSIS
What is the principle of a measurement with CHALLENGER?
Challenger is an Osteodensitometer, using the technology known as DEXA (Dual Energy X-ray Absorptiometry)
which itself is controlled a standard Pentium IV 1.4 GHz (minimum), 512 RAM computer running Windows XP.
The different possible examination sites are the spine, the femur and the forearm.
The X-ray source emits 3 intensities, 0.1mA, 0.4mA and 0.8mA. By assuring a count of X-rays that is not absorbed in
the same way in the air, the soft tissue and the bone, the software provides the density of the measured site.
Challenger then provides:

 the Bone Mineral Density (BMD expressed in g/cm²) which represents the density of bone
 The Bone Mineral Content (BMC expressed in g) which represent the dry (ashed) mass of bone.
These parameters are given for each selected analysis area (either automatically or manually) on the image obtained
with the examination.
Why using x-ray
The various technical approaches to bone mineral measurements using X-rays have the advantage to be understood in
terms of photon interactions with matter.
Dual X-ray Absorptiometry replaced the radionuclide source of Dual photon Absorptiometry previously used with an
X-ray tube, which has its origins in the 1970’s with the X-ray spectophometry.
This technique improved the performance of bone densitometers by combining higher photon flux with a smaller
diameter source. The availability of an intense, narrow beam of radiation shortened examination times, enhanced
image definition and improved precision. Another advantage of DXA is the relative stability of verification in clinical
use.
Why a measurement at the Spine, Femur or Forearm?

Whole body DXA studies give comprehensive information on total body bone density, bone mineral content and soft
tissue composition. Still the spine, the femur and the forearm are regarded as the most important measurement regions
as they are frequently sites of Osteoporotic fractures that considerably affect the quality of life, and can be a cause of
morbidity and mortality.
Is there any potential danger in this examination?
Clinicians requesting and technologists performing scans should be aware that any exposure to ionizing radiation
carries a risk.
However, studies of radiation exposure to patients from DXA scans have confirmed that dose levels are small
compared with many other radiological investigations involving ionizing radiation. With diagnostic procedures this is
always very small, and especially for bone densitometry studies where radiation levels are often so low that, for
example, the scatter dose to the operator from some pencil beam systems can be difficult to detect and quantify
accurately.
The risks involved are the induction of cancer by exposure to radiation and for women with child bearing potential,
genetic injury to future children. These risks are comparable to a risk of death in aeroplane accident, which means due
to chance, and increase in proportion to the exposure to it, that is to say to radiation.
However, it has not proved easy to quantify the risks of radiation because cancer has many other causes unrelated to
radiation.
Some risks in life comparable to having a DXA study are listed in table
Some activities carrying a risk of death comparable to receiving an effective dose of 1µSv from a DXA
examination (data from Pochin).
Exposure to natural background radiation for 4 hours
Smoking one-tenth of a cigarette
Traveling 3 miles in an aero plane
Etc.
What is T-score?
The T-score represents the deviation between your value and the average value of a young healthy person of your sex
and ethnic. If your T-score is higher than –1, you are regarded as “normal”. If your T-score is comprised between –1
and –2.5, you have Osteopenia, i.e. low bone mass. This is not osteoporosis yet, but you should already consider a
treatment and/or changing your diet and physical activity. If your T-score is lower than –2.5, you have Osteoporosis.
What is Z-score?
The z-score represents the deviation between your value and the mean value in a population subject of the same age.
For young subjects, i.e between 20 and 40, there is no significant difference between Z-score and T-score.
For older patients however, the bone density decreases and it is normal to observe a decreasing of T-score.
Z-score is then useful to determine if the low density of an old patient is due to the normal decreasing of bone density
with age. (In this case the Z-score is close to 0), or if there is a high risk of fracture (in this case, Z-score is negative).
What is the reliability of the results?
The key to the use of physical measurements in clinical trials is to ensure the consistency of the data for each patient.
Dual-energy X-ray Absorptiometry (DXA) measurements are the currently accepted standard for the measurement of
bone density. Indeed, it is known for its high precision, low radiation dose and long term stability of verification and
has been widely used in trials of new pharmaceuticals to prevent bone loss or treat Osteoporosis.
For DXA, the reliability of an instrument is assessed by daily measurements of phantoms, which permits to regularly
measure the coefficient of variations of the machine.
An important element of consistency is also to ensure that the same anatomical region is scanned in exactly the same
position each time the patient attends for a measurement. Following this the examination must be analyzed in the same
manner, selecting an identical region of interest.
What you should know about osteoporosis?
Osteoporosis is a condition that thins and weakens your bones, making you more likely to break (fracture) bones, even
from minor knocks, bangs, or falls. People with osteoporosis most commonly experience fractures of the spine, hip or
wrist.
There are approximately 25 million people in the world affected by this « silent » disease, and most of them are not
even aware of the condition until a fracture occurs. Although osteoporosis is a significant health problem for many
people in the world, it is most common in middle-aged women. As many as one in three women, or one in five men
over the age of 50, will suffer a fracture related to osteoporosis during their lifetime.
What causes osteoporosis?

Your bones are made of living tissue. Although you are not aware of this, your bones are always changing. Both are
being eroded and rebuilt in two, ongoing activities which together are called “remodelling”.
In your teens and twenties, the “rebuilding” dominates, and your bones get stronger and stronger. In your thirties and
forties, the two activities more or less balance each other out, and your bones reach their peak strength. Peak bone
strength depends on many factors, including genetics, lifestyle (diet and exercise), medication and chronic illness.
After the age of forty, the “eroding” bone becomes dominant, and over time your bones gradually weaken.
Normally, there is no cause for concern – remodelling is part of the natural life cycle for us all. However, if you
develop osteoporosis, “rebuilding” of the bone slows down earlier, or their “eroding” speeds up, or both. With
osteoporosis, the net result is that your bones become weaker than those of other people your own age and you have a
greater tendency to fracture do.
Who is prone to osteoporosis?

If you are a postmenopausal woman, you are in the group who will most likely be affected by osteoporosis. With the
onset of menopause, your body slows its production of an important hormone, called oestrogen. This hormone is
important during your reproductive years, and also helped to maintain your bones strong.
There are other risk factors that may lead to osteoporosis. These include a family history of osteoporosis, a small and
light body frame, smoking, and alcohol consumption, a lack of exercise, and long-term use of certain drugs such as
corticosteriods, and an early menopause.
How do you check if you are at risk?

The best place to start is your doctor. He or she will review your medical history, and if there is concern for
osteoporosis, he/she may advise you to have a bone check-up. The results of this test, combined with your medical
history, will help your doctor decide if you have, or might develop osteoporosis.
What kind of bone check-ups is there?

Until the 1970’s and 1980’s, the best way to check your bones was to x-ray your hip or spine. An experienced
radiologist could then analyze the x-ray and identify the condition of your bones. Unfortunately, weak bones are only
visible once they are damaged and have partially collapsed. Making this type of test ineffective as an “early warning
system”, as well as being unwise to expose patients to unnecessary x-ray radiation. Safer and better ways have since
been developed to ensure earlier and more effective bone testing.
In the 1970’s and 1980’s, special radiological tests were developed to help detect osteoporosis earlier. These tests are
called Bone Mineral Density (BMD) tests. BMD has been the most popular method for checking the healthiness of the
bone. Its measurement tells the doctor how much bone there is at a particular site on your body, referred to as your
bone density. The lower the density means the weaker your bone, and the more prone you are to having a bone
fracture. This type of measurement can be performed on various sites such as the spine, hip, arms and legs. BMD
measurements also involve x-ray radiation, although at lower levels than traditional x-rays.
In 1997, a new technology was approved by the U.S. Food and Drug Administration for testing bones. This new
method, called “Bone Sonometry” is based on ultrasound, similar to the one used by doctors to check the progress of
pregnant women and their unborn child.
BMD and Bone Sonometry are not always used on the same sites of the body, and the results of the tests are not
always the same. Each technology measures different parts of the body. Nevertheless, since osteoporosis is a
generalized disease, affecting your entire skeleton, it can be detected on various body sites. Your doctor understands
this, and knows how to interpret the results so that helped by him/her; you can make more informed decisions about
your health.
What should you wear?

The main interfering conditions lay in metal objects such as belts buckles, coins, truss, corset, underwired bra, buttons
or zipper. The patient should be careful to remove them prior to the examination.
How long does this check-up take?
The examination length varies according to the speed selected in the patient database prior to an examination
performance.
In theory, the time attributed to an examination is:
 Spine examination : 3-6min
 Femur examination : 4-7 min
 Forearm examination : 2-4 min
Test results and their meaning?
1. The higher the density, the healthier your bones are.

2. Your results are compared with the results of a typical young person of the same sex, and are given by a unit of
measure called the “T-Score”.
3. Your results are also compared to those typical of your own age and sex, and is summarised by a unit of measured
called “Z-Score”
All this information is then printed out onto a report showing the image of your scanned bone along with the results.
Your doctor knows how to interpret the numbers and the results, and can discuss with you what they mean.
What should you do with your results?
Your doctor will advise you as to what best to do. If your test results indicate that your bones may be weak, he / she
will probably suggest preventive measures (like increasing his calcium or vitamin D to prevent the weakness of the
bone mass) and /or prescribe medication (like oestrogenic treatment). How long the doctor helps you to care for
yourself depends on many factors.
In any case you can daily help yourself by:
 Eating healthy foods.

 Making sure your diet includes enough calcium and vitamin D (very important for building
strong bone – for example, dairy products, fish with bones like sardine’s etc).
 Doing some weight bearing exercise (where your body supports its own weight, like walking,
jogging, and aerobics. Swimming is a great exercise for your heart and easy on your joints, but
it is not the best choice for strengthening your bones).
 Avoid heavy smoking and alcohol consumption.
Chapter 16 Trouble-shooting
16 Trouble-shooting
 If any of the following problems keeps occurring, please contact your after-sales service.
16.1 During the Auto verification
16.1.1 The X-ray count is very low (0, 1, 2, 3)
1) There is no X-ray emission

 Switch off the CHALLENGER and switch it on few seconds later. Error message: Base line adjustment
16.1.2 Error message : Base line adjustment
1) The result of the previous verification and the result of the installation day reference verification are not close
from each other.
 If the variation is only about 2 or 3 channels, and only in this case, you can accept the adjustment. But you
must be very careful that the red color is still on the second big peak. Otherwise do not accept.
2) While the auto verification, the patient lays his arm between the X-ray source and the detector
 Ask the patient to put his arms under his head and do the verification again
16.2 During the examination performance
1) The quality of the Examination Image is poor
 If the image becomes deformed after an examination, this should be considered that there is a problem with the
machine, and the User should contact the authorized representative of DMS for advice.
 Please note that if there is a slight displacement of the image, it is possible that the patient moved during the
examination. This should be confirmed by the patient. If the patient moved, the examination should be repeated as
many times as possible provided the recommended acceptable yearly doses are not acceded.
2) The warning light ON is turned off
 Ensure that the cable for power supply is connected to a socket with ~230 Volt and 50 Hz.
 Confirm that the socket supplies the correct voltage required for the device.
3) The machine’s arm does not move
 Confirm that the device is switched on.

 Confirm the connections between machine and computer with the serial cable
4) No x-rays are emitted
 If the machine is switched on but no x-rays are emitted while scanning confirm the connections of the serial cable
between computer and machine.
5) The control panel does not work
 Be sure that you are working in remote control mode
Chapter 17 General Specifications
17 General Specifications
17.1 Declaration of Conformity to International Standards
The device is in specification with regulations:
 IEC 60601-1-1
 IEC 60601-1-2
 IEC 60601-1-3
 IEC 60601-1-4
17.2 X-ray Exposure Levels
Dose to patient (approximately in standard working conditions)
Type of survey scanning time in minutes Max. estimated dose in SV

Spine 3/6 20
Femur 4/7 20
Forearm 2/4 10
Dose to the Operator
Distance of the operator from Densitometer Max. estimated dose in SV/h

30 cm 3
1m < 0.3
17.3 Quality Control
On line with storage of measurements on a built in reference body every time an examination is performed. Statistical
control of these values.
17.4 Specification of Accessories
!Use only accessories / Peripheral devices conforming with IEC standards

17.4.1 Computer
Recommendation of the following specifications for a minimum Configuration:
 CPU Intel PENTIUM IV 1.4 GHz

 512 Mb RAM minimum
 100 GO UDMA Hard disk minimum
 SVGA PCI 64Mo
 CDROM x 24 x 24 x 52
 Windows XP
17.4.2 Monitor
Recommendation of the following specifications of monitor:
 15”or 17” SVGA (or larger)
 Approved CE
 1024x768 minimum
17.4.3 Printer
Recommendation of the following types:
 Hewlett Packard DeskJet color
 Epson Stylus Color
17.5 Electric Data
 Voltage supply ~110 / 230 V 50-60 Hz

 Power absorbed 450 W
17.6 Mechanical Data
 CHALLENGER ENVISION Mobile
Dimensions:
 During transportation (Folded) : 77 x 122 x 137 cm
 During operate (Unfolded) : 197 x 122 x 137 cm
Weight:
 ca. 200 kg
 CHALLENGER ENVISION Table
Dimensions:
 During transportation (taken apart) : 77 x 122 x 137 cm
 During operate (assembled) : 197 x 122 x 137 cm (79”x 45”x55”)
Weight:
 ca. 300 kg
17.7 Environmental Operating Conditions
 Temperature 17° - 32° C. (60°-90°F)

 Relative humidity 20 - 80%.(non-condensing)
17.8 Operating Space Requirements

Recommendation to provide the following space requirements:
Figure - 294 - Environmental Layout
17.9 Environmental Storage & Transport Conditions

 Temperature : -10°C to +50°C (-14°F to +117°F)
 Humidity : 10% to 90% RH (no condensation)
 Pressure : 700mBar – 1060mBar
17.10Communication
 Serial interface RS232 standard.
17.11Range and Accuracy of Clinical Parameters
Clinical Parameter Range

- Bone Mineral Density (BMD) : 0.3 – 1.4
- Age Range : 15 – 95 years old
(Statistical data exists for these age groups; however the lack of statistical data does not mean to say
that patient examinations cannot be carried out outside this age range.)
- Weight < 200kg
(Limited advisable based on the space available between the X-ray detector and the bed for a patient
to fit).
Clinical Parameter Accuracy

- Bone Mineral Density (BMD) : +/- 1.5% in vivo (+/- 1.0% in vitro)
17.12Data sheet of the X Ray system
17.12.1 X-ray monoblock
manufactory Bosello
x ray tube model XRG 95.IT
work conditions tube 95 KVolt 1 mA max.
dimensions of x ray beam  2 mm at source spot
30mm a 40 cm on axis
17.12.2 Collimator
material : brass
height : 45 mm
hole diameter : 2 mm
patient skin collimator distance: 50 mm
patient skin focus x-ray tube distance: 145 mm
radiation exposure: <0.3Gy/h a 1mt.
3.0 Gy/h a 30 cm.
Exposure at patient skin: 700 Gy/h
17.12.3 Patient doses (estimated values in normal working conditions)
kind of survey execution time (min.) Max. estimated Sv Approx. qty examinations / year
spine 5 33,3 30
femur 5 33,3 30
forearm 2 6.9 150
Chapter 18 References / bibliography
18 References / bibliography
[1] Blake Glen M, Wahner Heinz W, Fogelman Ignac The evaluation of Osteoporosis: Dual Energy x-ray
Absorptiometry and Ultrasound in Clinical Practice - Second Edition -, Martin Dunitz LTD 1999
Chapter 19 Glossary
19 Glossary
This chapter will explain the meaning of the elements on the analysis window and give some medical and technical
terms definitions.
19.1 Elements constituting the analysis windows
Spine profile : represents

the total density of the
Intervertebral vertebrae on one line
disc between the spine outline.
L4 Vertebra
Soft tissues
Result board
(Refer to Tableau
21 p.205

ROI Region of Interest.
BMD (g/cm²) Gives the bone mineral density of the area analyzed in g/cm².
Z-score Situates the patient in a population composed of persons of his age for the analyzed area.
T-score Situates the patient in a teenage population for the analyzed area.
 If T-score > -1, the patient is considered to have a normal BMD
 If – 2,5< T-score <-1, the patient is considered to be osteopenic
 If T-score < -2,5, the patient is considered to be osteoporotic.
According to the WHO (Wold Health Organization).
Tableau 21
Chapter 19 Glossary
Normality curve:
situates the
patient’s results
among the
average
population for an
analysis (Refer to
13 T-score, Z-
score and
Reference Curve
p.34
T-score and Z-score (refer

to Tableau 21 p.205 and to
13 T-score, Z-score and
Reference Curve p.34)
Figure 296 - Spine validated baseline
Green Characterizes a patient with a normal BMD.

Area between the dark lines Characterizes a patient with a BMD around the average
Yellow Characterizes a patient with a probable Osteopenia
Red Characterizes a patient with a probable Osteoporosis
Tableau 22
Chapter 19 Glossary
Gives information
where the cursor
is positioned as
well as on the
bone high and low
energy where the
cursor is
positioned.
(Refer to Tableau
23 p.207)
Analysis
Figure 297
results for L2,
Figure 298 – Validated spine analysis area L3 and L4
X Horizontal position of the mouse’s cursor

Y Vertical position of the mouse’s cursor
BMD Bone density where the cursor is positioned
Tableau 23
19.2 Terms and abbreviations used in this volume
Machine: Examination system to perform a survey.
Movement control: Electronic circuit designed to control a step by step motor.
BUS: Electronic circuit used to establish communication between two other electronic devices: digital and analogical
data, voltages etc. can be transmitted.
Serial cable: Cable to connect the serial port of the computer with the machine.
Wiring: Set of cables and connectors to connect the electronic circuits.
CPU: (Central processing unit) microprocessor.
Limit Switch: Microswitch, which reacts when a mechanical part of the machine reaches its initial or final position in
movement.
Photomultiplier: detector, which measures x-rays and produces an electric signal.
Fuse: Component, which has the purpose to protect electronic parts from excessive current.
KVolt: 1000 Volts.
Chapter 19 Glossary
Earth: Electrical contact with the same electrical potential as earth. To prevent electrical hazard and electromagnetic
interference it is obligatory to earth the device.
Step by step motor: Electric motor able to perform precise movements controlled by the movement control.
RS232: Type of serial port for communication with the computer.
Examination: Pointwise analysis of an area performed with the machine.
Temporiser: Electronic device, which produces an electric contact after a prefixed time.
Voltage supply: ~110 / 230 Volt 50 Hz.
Monoblock: X-ray emitter composed of a control board and an x-ray tube positioned in a cooling oil bath. All parts
are contained in a housing of lead to screen the x-rays.
COM1: Serial port No.1 for communication.

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User Manual

Dual Emission X – Ray Absorptiometry

Diagnostic Medical Systems

Parc de la Méditerranée - District de Montpellier - 34470 Pérols - France

Dual Emission X – Ray Absorptiometry

Diagnostic Medical Systems

Parc de la Méditerranée - District de Montpellier - 34470 Pérols - France

1 INTRODUCTION AND BACKGROUND INFORMATION.................................................3

1 Introduction and Background Information

1.5 Adverse Effects

1.6 Maintaining device effectiveness

1.7 Use in specific Populations

1.8 Equipment supplied with CHALLENGER and set-up instructions

This manual provides a detailed breakdown of the CHALLENGER package.

1.9 System safety / Conformance to standards

The CHALLENGER system’s system safety is detailed in this manual.

1.10 Operators manual

1.11 Patient counseling information

1.12 Contacting DMS

2 Using this manual

2.2.1 User's Manual

© Copyright 1997 by D.M.S. - All rights reserved.

© Copyright 1997 by D.M.S. - All rights reserved.

2.3 Customer Feedback

Tel.: (33) 4 67.50.49.00

Internet web site: http://www.dms.com

The 3 sites are themselves composed into several different parts:

Challenger then provides the following parameters:

Figure 1 –CHALLENGER ENVISION MOBILE device

Figure 2 –CHALLENGER ENVISION STATIONARY device

4.2 Period of warranty

The period of warranty is stated in the user's documentation.

4.3 Limits of warranty

Items not covered by warranty

5.2 Cleaning the Phantom

6.1 Preventative Maintenance

6.2 Customer Responsibility

6.3 Visual Inspection

Check Challenger regularly for exterior damage, including all cables.

6.4 Electrical Maintenance

An authorized representative of DMS shall carry out all other maintenance.

6.5 Mechanical Maintenance

An authorized representative of DMS shall carry out all other maintenance.

6.6 Compulsory Maintenance

Important: the average life span of the x-ray source is 5 years.

If there is a doubt, please contact the qualified DMS representative.

8 Environmental conditions that affect use

8.1 Operating conditions

CHALLENGER should be operated within the following conditions:

8.2 Storage conditions

CHALLENGER should be stocked within the following conditions:

8.3 Moving the CHALLENGER

 Every time the CHALLENGER is moved, verification must be done.

8.4 Chair recommendations (valid only for the forearm examination)

9 Symbols & Labels Used

Type B Equipment: classification according to the

Keep the equipment in a standing position.

Fragile, Handle with care.

Do not allow getting wet.

Approval of this unit to the European Community

9.2 Symbols used in this manual

 Important note : to be read and understood

  Stop: there is a choice of options

Hint / Advice for advanced learners.