Stratos DR - Anglais - 00 [PDF]

Zitiervorschau

Operator’s Manual DMS GROUP – Parc de la Méditerranée 34470 Pérols – France Tél + 33 (0)4 67 50 49 00 - Fax +33 (0)4 67 50 49 09 Email: [email protected] STRATOS DR_anglais_00

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Operator Manual – STRATOS DR

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IMPORTANT ! X-ray Protection X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED X-ray equipment, if not properly used, may cause injury. Accordingly, the instructions herein should be thoroughly read and understood before attempting to place this equipment in operation. We will be glad to assist and cooperate in placing this equipment in use. Although this apparatus is built to the highest safety standards and incorporates a high degree of protection against X-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves or others to X-radiation. It is important that everyone working with X-radiation be properly trained and take adequate steps to insure protection against injury. The manufacturer assumes that all operator and service personnel authorized to use, install, calibrate and maintain this equipment are aware of the danger of excessive exposure to Xradiation, are sufficiently trained and have the required knowledge for it. The equipment herein described is sold with the understanding that the manufacturer, its agents, and representatives are not liable for injury or damage, which may result from exposure to X-radiation. Various protective material and devices are available. It is recommended to use such materials and devices.

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Operator Manual – STRATOS DR

ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM This equipment or system contains environmentally dangerous components and materials (such as PCB‘s, electronic components, used dielectric oil, lead, batteries etc.) which, once the life-cycle of the equipment or system comes to an end, becomes dangerous and need to be considered as harmful waste according to the international, domestic and local regulations. The manufacturer recommends to contact an authorized representative of the manufacturer or an authorized waste management company once the life cycle of the equipment or system comes to an end to remove this equipment or system.

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TABLE OF CONTENTS 1 INTRODUCTION AND BASIC INFORMATION: ESSENTIAL PRESCRIPTIONS ........................................ 10 1.1 DEVICE DESCRIPTION .............................................................................................................................................. 11 1.2 CONTRA-INDICATIONS ............................................................................................................................................ 11 1.3 WARNINGS ............................................................................................................................................................. 11 1.4 PRECAUTIONS ......................................................................................................................................................... 12 1.5 WARNINGS ABOUT SOFTWARES .............................................................................................................................. 12 1.6 SIDE EFFECTS .......................................................................................................................................................... 13 1.7 MAINTAINING THE EFFICIENCY OF THE DEVICE....................................................................................................... 13 1.8 TARGET PUBLIC ...................................................................................................................................................... 14 1.9 EQUIPMENT SUPPLIED WITH STRATOS DR AND INSTALLATION INSTRUCTIONS .................................................... 14 1.10 SYSTEM SAFETY/COMPLIANCE WITH THE STANDARDS ......................................................................................... 14 1.11 OPERATOR DESCRIPTION....................................................................................................................................... 14 1.12 USER MANUAL ..................................................................................................................................................... 15 1.13 PATIENT INFORMATION........................................................................................................................................ 15 1.14 CONTACTING DMS............................................................................................................................................... 15 2

USING THIS MANUAL...................................................................................................................................... 16 2.1 INFORMATION AVAILABLE IN THIS MANUAL ........................................................................................................... 17 2.2 COPYRIGHT............................................................................................................................................................. 17 2.2.1 User Manual................................................................................................................................................ 17 2.2.2 Software ....................................................................................................................................................... 17 2.3 CUSTOMER FEEDBACK ........................................................................................................................................... 18

3 DEVICE DESCRIPTION ........................................................................................................................................... 19 4 WARRANTY CONDITIONS..................................................................................................................................... 21 4.1 D.M.S WARRANTY SYSTEM .................................................................................................................................... 22 4.2 WARRANTY PERIOD................................................................................................................................................ 22 4.3 WARRANTY LIMITS ................................................................................................................................................. 22 5 UPKEEP ....................................................................................................................................................................... 23 5.1 UPKEEP OF STRATOS DR: .................................................................................................................................... 24 5.2 UPKEEP OF THE PHANTOM ...................................................................................................................................... 24 6 MAINTENANCE......................................................................................................................................................... 25 6.1 INFORMATION ......................................................................................................................................................... 26 6.2 PREVENTIVE MAINTENANCE................................................................................................................................... 26 6.3 CUSTOMER RESPONSIBILITY ................................................................................................................................... 26 6.4 VISUAL INSPECTION ................................................................................................................................................ 26 6.5 ELECTRICAL MAINTENANCE................................................................................................................................... 26 6.6 MECHANICAL MAINTENANCE ................................................................................................................................. 26 6.7 COMPULSORY MAINTENANCE ................................................................................................................................. 26 7 ENVIRONMENTAL CONDITIONS ........................................................................................................................ 27 7.1 INFORMATION ......................................................................................................................................................... 28 7.2 CONDITIONS OF USE ................................................................................................................................................ 28 7.3 STORAGE CONDITIONS ............................................................................................................................................ 28 7.4 CONDITIONS OF CARRIAGE (DELIVERY EXCLUDED) ................................................................................................ 28 8 SYMBOLS & ABBREVIATIONS ............................................................................................................................. 29 8.1 SYMBOLS USED ON THE DEVICE AND ITS PACKAGING ............................................................................................. 30 8.2 SYMBOLS USED IN THIS MANUAL ............................................................................................................................ 31 8.3 TAGS....................................................................................................................................................................... 31 8.3.1 Manufacturer’s tag ..................................................................................................................................... 31 8.3.2 Tag signaling X-Ray emission .................................................................................................................... 31 8.3.3 Year of manufacture ................................................................................................................................... 32 8.3.4 Adress of the manufacturer ........................................................................................................................ 32 8.3.5 Tag signaling laser beam emission............................................................................................................. 32 8.3.6 Caution: Refer to available documentation................................................................................................ 32 STRATOS DR_anglais_00

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Operator Manual – STRATOS DR 8.3.7 Danger: High voltage.................................................................................................................................. 33 8.3.8 Tag of the atmospheric conditions and the conditions of carriage (On the packaging)........................... 33 8.3.9 Danger of crushing ..................................................................................................................................... 33 8.3.10 Respect of the DEEE norm (when available)........................................................................................... 33 9 EQUIPMENTS SUPPLIED WITH STRATOS DR AND INSTALLATION INSTRUCTIONS ........................ 34 9.1 EQUIPMENT SUPPLIED WITH STRATOS DR ........................................................................................................... 35 9.2 UNPACKING STRATOS DR ................................................................................................................................... 35 9.3 DEVICE INSTALLATION ........................................................................................................................................... 35 9.4 PROCEDURES OF ELECTRICAL CONNECTIONS .......................................................................................................... 36 9.5 CONTROL PANEL .................................................................................................................................................... 37 9.6 ELECTRICAL CONNECTION ..................................................................................................................................... 38 9.7 INSTALLING AN ADDITIONAL SIGNALLING LAMP INDICATING X-RAY EMISSION ..................................................... 38 9.8 SAFETY RULES ........................................................................................................................................................ 39 9.9 STARTING STRATOS DR ...................................................................................................................................... 39 9.10 INSTALLING THE SOFTWARE ................................................................................................................................. 39 10 SAFETY SYSTEM / COMPLIANCE WITH THE STANDARDS....................................................................... 41 10.1 LIABILITY OF THE MANUFACTURER ...................................................................................................................... 42 10.2 SPECIFICATIONS RELATING TO ELECTRICAL SAFETY ............................................................................................. 42 10.3 CATEGORY OF CLASSIFICATION (ACCORDING TO EN 60601-1 ART.5) .................................................................. 43 10.4 X-RAY EMISSION .................................................................................................................................................. 43 10.5 LASER LIGHT EMISSION ......................................................................................................................................... 43 10.6 EMERGENCY STOP BUTTON ................................................................................................................................... 43 10.7 EXPIRY OF SERVICE LIFE ....................................................................................................................................... 44 10.8 CERTIFICATION ..................................................................................................................................................... 44 10.9 SIGNALLING .......................................................................................................................................................... 44 10.10 PERSONAL DOSIMETERS ...................................................................................................................................... 45 11 DXA PRINCIPLE...................................................................................................................................................... 46 11.1 GENERAL THEORY ON THE DUAL EMISSION X-RAY ABSORPTIOMETRY ................................................................. 47 11.2 RESULTS ............................................................................................................................................................... 48 11.2.1 AP-Spine .................................................................................................................................................... 49 11.2.2 Proximal femoral bone.............................................................................................................................. 49 11.2.3 Forearm ..................................................................................................................................................... 49 11.2.4 Whole Body................................................................................................................................................ 49 12 T-SCORE , Z-SCORE AND REFERENCE CURVE : .......................................................................................... 50 12.1 T-SCORE ............................................................................................................................................................... 51 12.2 Z-SCORE ............................................................................................................................................................... 51 12.3 REFERENCE CURVE ............................................................................................................................................... 52 13 USER MANUAL....................................................................................................................................................... 53 13.1 STARTING THE SCANNER; PRESENTATION OF THE SOFTWARE ............................................................................... 55 13.1.1 Activating the scanner and opening the software .................................................................................... 55 13.1.2 Presentation of the software...................................................................................................................... 56 13.2 CARRYING OUT AN EXAMINATION AND ANALYZING IT : ....................................................................................... 59 13.2.1 Examination sequencing: ......................................................................................................................... 59 13.2.2 Examination area :.................................................................................................................................... 62 13.2.3 How to launch a scan:............................................................................................................................... 63 13.2.3.1 How to carry out an examination on an existing patient: .........................................................................................64 13.2.3.2 How to add a new patient.........................................................................................................................................64 13.2.3.3 How to select the examination mode .......................................................................................................................66 13.2.3.4 How to carry out an examination .............................................................................................................................67 STEP 1: SELECTION OF THE SITE AND DETERMINATION OF THE EXAMINATION PARAMETERS: ...............................................................................................................................................................68 STEP 2: POSITIONING OF THE PATIENT .......................................................................................................73 STEP 3: POSITIONING OF THE LASER ............................................................................................................78 STEP 4: ACQUISITION..............................................................................................................................................81 STEP 5: ANALYSIS OF THE EXAMINATION...................................................................................................85

13.2.4 How to read an examination..................................................................................................................... 86 13.2.4.1 Changing the ROI ....................................................................................................................................................87 13.2.4.2 Changing the contrast ..............................................................................................................................................88 13.2.4.3 Changing the mask...................................................................................................................................................89

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13.2.4.3.1 Parametering the zoom ....................................................................................................................................89 13.2.4.4 Reading the results...................................................................................................................................................91 13.2.4.5 Displaying the patient follow-ups ............................................................................................................................92 13.2.4.6 Compare two analysis of the same patient ...............................................................................................................92 13.2.4.7 Modify the name of the ROI ....................................................................................................................................97 13.2.4.8 Print the medical report............................................................................................................................................99

13.2.5 Handle an analysis .................................................................................................................................. 101 13.2.5.1 Reading and Modification of the spine analysis ....................................................................................................102 13.2.5.2 Reading and Modification of the femur analysis ...................................................................................................108 13.2.5.3 Reading and Modification of the forearm analysis ................................................................................................113 13.2.5.4 Reading and Modification of the whole body analysis ..........................................................................................120

13.2.6 Morphometric Measures: surface, distance and angle .......................................................................... 123 13.2.7 Structural analysis of the femur: ............................................................................................................ 125 13.2.7.1 Introduction: ..........................................................................................................................................................125 13.2.7.2 Use and interface: ..................................................................................................................................................126

13.2.8 FRAX Tool: ............................................................................................................................................. 129 13.2.8.1 Introduction: ..........................................................................................................................................................129 13.2.8.2 FRAX Tool interface: ............................................................................................................................................129 13.2.8.3 FRAX Tool documentation:...................................................................................................................................131 13.2.8.4 Lateral BMD acquisition (Option) .........................................................................................................................134 13.2.8.5 Digital Vertebral Assessment (DVA) acquisition (Option)....................................................................................135

13.2.9 Paediatric skeletal age............................................................................................................................. 138 13.2.10 Orthopaedics module: ........................................................................................................................... 140 13.2.10.1 Introduction: ........................................................................................................................................................140 13.2.10.2 Orthopedic femur:................................................................................................................................................141 13.2.10.3 Orthopedic AP knee:............................................................................................................................................143 13.2.10.4 Orthopedic lateral knee: .......................................................................................................................................145 13.2.10.5 Orthopedic shoulder:............................................................................................................................................147 13.2.10.6 Orthopedic elbow:................................................................................................................................................149 13.2.10.7 Analysis by the management of masks: ...............................................................................................................151 13.2.10.8 Interface and functionality: ..................................................................................................................................151 13.2.10.9 Orthopedic regions of interest:.............................................................................................................................156

13.3 RE-VIEWING AN EXAMINATION ........................................................................................................................... 162 13.3.1 Open the section « Re-view an examination »........................................................................................ 162 13.3.2 Displaying an analysis after a selection by familly name ...................................................................... 163 13.3.3 Displaying an analysis after a selection by examination or by date ...................................................... 164 13.3.4. Displaying the patient’s follow-up ......................................................................................................... 167 13.3.5 Printing the medical report ..................................................................................................................... 175 13.4 DATA MANAGEMENT .......................................................................................................................................... 177 13.4.1 Open the “data management” file .......................................................................................................... 177 13.4.2 How to carry out a search ....................................................................................................................... 178 13.4.2.1 Searching data within the database ........................................................................................................................178 13.4.2.2 Searching data by patient .......................................................................................................................................180 13.4.2.3 Searching data by examination ..............................................................................................................................182

13.4.3 How to manage a patient file ................................................................................................................. 183 13.4.3.1 “Modify”: modify an analysis or update the patient data.......................................................................................184 13.4.3.2 ”Delete”: deleting the analysis or the patient file...................................................................................................186 13.4.3.3 “View scan”:review an analysis before modifying it .............................................................................................187 13.4.3.4 “Print”....................................................................................................................................................................187 13.4.3.5 “Add”.....................................................................................................................................................................188

13.4.4 How to import a Database: ..................................................................................................................... 189 13.4.4.1 Run importation: ....................................................................................................................................................189 13.4.4.2 Review imported examination: ..............................................................................................................................190

13.4.5 How to record a paper examination: ...................................................................................................... 191 13.4.5.1 Create or select a patient: .......................................................................................................................................191 13.4.5.2 Add a scan manually:.............................................................................................................................................192 13.4.5.3 Review the scan: ....................................................................................................................................................193

13.5 ARCHIVING THE EXAMINATIONS ......................................................................................................................... 195 13.5.1 Opening the Archiving section: .............................................................................................................. 195 13.5.2 Archiving conditions configuration:................................................................................... 196 13.5.3 Archiving section presentation................................................................................................................ 198 13.5.4 Selecting an archived examination......................................................................................................... 199 13.5.5 Archiving an examination....................................................................................................................... 202 13.6 QUALITY CONTROL ............................................................................................................................................. 205 13.6.1 Opening the quality control file .............................................................................................................. 205 13.6.2 Performing a quality control................................................................................................................... 206 13.6.3 Viewing previous controls ....................................................................................................................... 209 STRATOS DR_anglais_00

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Operator Manual – STRATOS DR 13.6.4 Consulting the quality control results..................................................................................................... 210 13.6.5 Exporting a file........................................................................................................................................ 216 13.6.6 Printing the graph and results ................................................................................................................ 217 13.6.7 Exiting the quality control file ................................................................................................................ 218 13.7 SOFTWARE CONFIGURATION ............................................................................................................................... 220 13.7.1 Database .................................................................................................................................................. 221 13.7.2 Archiving ................................................................................................................................................. 222 13.7.3 Language ................................................................................................................................................. 223 13.7.4 Normality curves ..................................................................................................................................... 224 13.7.5 Editor of normality curves: ..................................................................................................................... 225 13.7.5.1 Warning: ................................................................................................................................................................225 13.7.5.2 Presentation: ..........................................................................................................................................................225 13.7.5.3 Description:............................................................................................................................................................226 13.7.5.4 Creation of a curve:................................................................................................................................................226

13.7.6 Examination parameters......................................................................................................................... 228 13.7.7 Calculation .............................................................................................................................................. 229 13.7.8 Printing.................................................................................................................................................... 230 13.7.9 Printing of multiple examinations (more than three): ........................................................................... 231 13.7.9.1 Selection of the examinations: ...............................................................................................................................231 13.7.9.2 Printing report:.......................................................................................................................................................232

13.7.10 Information about the medical institute ............................................................................................... 233 13.7.11 Preheating of the source and quality control ....................................................................................... 234 13.7.12 E-Mail.................................................................................................................................................... 235 13.7.13 Contact................................................................................................................................................... 236 13.7.14 Comments .............................................................................................................................................. 237 13.7.15 Letter editor (to the patient) ............................................................................................... 238 13.7.16 Letter editor (to the doctor)................................................................................................. 239 13.7.17 Maintenance .......................................................................................................................................... 240 13.7.18 Printing on DICOM format .................................................................................................................. 241 13.7.19 Configuration parameters ..................................................................................................................... 249 13.8 EXITING THE PROGRAM ....................................................................................................................................... 250 14 PATIENT INFORMATION................................................................................................................................... 251 15 TROUBLESHOOTING .......................................................................................................................................... 257 15.1 DURING THE AUTOMATIC CALIBRATION ............................................................................................................. 258 15.1.1 The X-Ray counts are very slow (0, 1, 2, 3, …) ...................................................................................... 258 15.1.2 Error message: baseline adjustment....................................................................................................... 258 15.2 DURING SCANNING ............................................................................................................................................. 259 15.2.1 Poor image quality .................................................................................................................................. 259 15.2.2 The signal lamp is off.............................................................................................................................. 259 15.2.3 The scanner’s arm does not move........................................................................................................... 259 15.2.4 No X-Ray emitted .................................................................................................................................... 259 15.2.5 The control panel does not work............................................................................................................. 259 16 GENERAL SPECIFICATIONS............................................................................................................................. 260 16.1 DECLARATION OF COMPLIANCE WITH INTERNATIONAL STANDARDS ................................................................... 261 16.2 EXPOSURE LEVEL TO X-RAY............................................................................................................................... 262 16.3 ACCESSORIES SPECIFICATIONS ............................................................................................................................ 263 16.3.1 The computer........................................................................................................................................... 263 16.3.2 The screen................................................................................................................................................ 263 16.3.3 The printer ............................................................................................................................................... 263 16.4 OPERATING CONDITIONS ..................................................................................................................................... 263 16.5 COMMUNICATION ............................................................................................................................................... 263 16.6 FUSES.................................................................................................................................................................. 264 16.7 MECHANICAL DATA ............................................................................................................................................ 265 16.8 LAYOUT REQUIREMENTS ..................................................................................................................................... 265 16.9 ENVIRONMENTAL CONDITIONS OF STORAGE AND OF TRANSPORTATION ............................................................. 266 16.10 LIMITS AND SPECIFICATION OF THE CLINICAL PARAMETERS ............................................................................. 266 16.11 DATA SHEET OF THE X-RAY SYSTEM ................................................................................................................. 266 16.11.1 X-Ray monoblock .................................................................................................................................. 266 16.11.2 Collimator .............................................................................................................................................. 266 16.12 SOFTWARE ERROR MESSAGES: .......................................................................................................................... 267 STRATOS DR_anglais_00

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17 GLOSSARY ............................................................................................................................................................. 271 17.1 ELEMENTS ON THE ANALYSIS WINDOW ............................................................................................................... 272 17.2 TERMS AND ABBREVIATIONS USED IN THIS VOLUME ........................................................................................... 275

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STRATOS DR

1 Introduction and basic information: Essential Prescriptions

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1.1 Device description STRATOS DR is an bonedensitometer that uses the DXA technology (DUAL energy X-ray Absorptiometry). The system is monitored by a computer equipped with a - minimum – 2.8 GHz Pentium processor on Windows XP (or higher). It performs measurements of the bone density on various parts of the body such as the spine, the femoral bone, the forearm and the whole body using X-ray. It provides information for these parts on the projected area about the bone mineral content (BMC) the mineral bone density (BMD) and the bone homogeneity index (BHI). 1.2 Contra-indications All female patients liable to be pregnant should not, under any circumstances, undergo an examination without consulting their attending physician beforehand.

1.3 Warnings WARNING : Do not attempt to operate the equipment without first reading this manual or without having attended training courses with an approved representative of DMS WARNING : This machine generates a certain level of X-ray radiation. The local and international regulations must apply to the installation and to the operation of the machine. WARNING: If a female patient is or is liable to be pregnant, contact the patient’s physician before performing an X-ray scanning. WARNING: Do not look directly at the laser light. WARNING: Do not remove any part of the covering to get access to the internal elements. WARNING: Do not use portable cellular equipment (walkietalkies, radiotelephones and cell phones) in the vicinity during the operation, as this may affect the measurements. WARNING: If the image of the patient is distorted, the machine may be dysfunctional: refer then to Chapter « Troubleshooting ». STRATOS DR_anglais_00

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STRATOS DR

WARNING: According to the article 3.201 of the 60601-1-1 standard, the user's computer should not be installed in the vicinity of the patient if it does not comply the requirements of the 60601-1 standard or if it's not protected by an insulating sheath or an insulating transformer. WARNING: For the devices delivered in Denmark or in Australia, the power cable – which must comply with the standards in force in the country – will be supplied at the local distributor's costs. For any further information, contact this distributor.

1.4 Precautions PRECAUTION : Do not lie or sit on the scanner for purposes other than scanning. PRECAUTION : Stay in the room while performing the scanning. PRECAUTION : Restrict the room to authorized staff only. PRECAUTION : Use only accessories and peripheral devices in accordance with IEC Standards. PRECAUTION : Make sure that the correct voltages are set for the equipment to be connected to power supply.

1.5 Warnings about softwares WARNING : Log out from the device when you have finished to use it. WARNING : Monitor the activation of the X-ray generator through the indicating lamp on the keyboard. In case of malfunction, proceed as indicated in the chapter 16 'Troubleshooting'. WARNING : Before any kind of examination, check the positioning of the patient so that he doesn't hinder the movement of the arm.

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WARNING : If a defect is detected in the motor movement, stop the examination and re-start the software. WARNING : When saving the database, writing errors may appear on the hard disk. In this case, free space on this disk then try again to apply the backup procedure. Should the problem remain, contact the Customer Service of D.M.S that will tell you what to do. WARNING : The list of error feedbacks displaying on the screen of the computer when using the software in case of problem can be found at the end of this manual. Should one of these error messages appear, read the code on the screen and refer to the table to identify the problem. Keep this code, as it will help find out what kind of problem you are encountering and it will allow DMS to intervene as efficiently as possible if you need assistance. WARNING : Observe the indications on the positioning of the patient as they are described in this manual. WARNING : Before any examination, make sure the whole set of parameters has been configured as required by the operator. WARNING : DO NOT ERASE/MODIFY THE « C:/DMS » DIRECTORY. The user is responsible for the files he adds and/or overwrites in this directory.

1.6 Side effects The number of examinations carried out per patient should be kept to a minimum, and should not exceed European/International standards currently in force. To this day, there is no side effect that we know if the limits are abided by. For the public (patients), the maximum recommended dose is 1mSv/year. 1.7 Maintaining the efficiency of the device The physician/operator has to clean STRATOS DR once a week using a non abrasive cleaning solution to make sure the device remains clean and efficient.

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STRATOS DR

1.8 Target Public Any individual (patient) needing to be examined, except pregnant women or women liable to be pregnant. 1.9 Equipment supplied with STRATOS DR and installation instructions This manual provides a detailed description of the STRATOS DR device. A set of positioning cushions is supplied with the equipment, it enables to position the patients so that their bones are correctly exposed during the analysis. If you want to know how to use these cushions, see further in this manual. As an accessory, a phantom enabling to perform Quality Control is supplied with the equipment. To use it, refer to the 'Carry out a Quality Control' section of the present manual. 1.10 System safety/Compliance with the standards The STRATOS DR safety system is detailed in this manual. 1.11 Operator description Instruction Level :

Knowledge :

Linguistic understanding : Experience : Admissible disabilities :

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Graduate Radiographer Radiologist Doctor Rheumatologist Orthopaedic specialist The operator must know the bone morphology, and must know the use of DXA systems. The operator must be trained to the safety around the use of ionising radiations. He must have read the instructions to know all the modalities of the device and the positioning of the patient. The operator must be familiar with a medical examination lied on a table. He must know how to use a Personal Computer The STRATOS DR software and the instructions are translated in the in the language of the country where the device is installed. So, the operator must speak the language of the country where the device is installed. The operator must know the practices of the osteodensitometric examination Impairment of the view corrected by glasses or by contact lenses Light impairment of the audition

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1.12 User Manual This manual provides the operator all necessary instructions for the successful operation of the STRATOS DR device. 1.13 Patient Information A brochure intended to help the patients to understand the STRATOS DR technology and the performances of STRATOS DR is provided in this manual. 1.14 Contacting DMS Customer Service Department: Phone number: (33) 4 67.50.49.08 Fax number: (33) 4 67.50.49.07. The Customer Service Department can be contacted by email: Technical support: [email protected] Any other question: [email protected]

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STRATOS DR

2 Using this manual

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2.1 Information available in this manual • This handbook contains the latest information available at the time of writing. • It may be periodically updated. Every change will be integrated in the form of an update. • Updates issued before the new edition shall contain additional (or replacement) pages to be inserted by the user in the original. • A new edition shall be published if a complete update of the manual is necessary. • DMS reserves the right to modify at any time the product or the software described in this user’s guide. 2.2 Copyright 2.2.1 User Manual No part of this manual 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 2010 by DMS - All rights reserved. 2.2.2 Software

This software may not in part or in whole, be reproduced or translated into another media or into another language without prior wirtten permission by Diagnostic Medical Systems. © Copyright 2010 by DMS - All rights reserved. The information in this document may be subject to change without prior notice and without any liability on the part of DMS

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STRATOS DR

2.3 Customer Feedback DMS acknowledges the importance of customer feedback and advises users to contact DMS for any suggestions or questions about either the equipment or the manual. Should you notice a mistake or misprint on one of the pages of this manual, please return a photocopy of the page involved to the address below DMS Parc de la Méditerranée District de Montpellier 34470 Pérols FRANCE Website: E-mail:

http://www.dms.com [email protected]

Tel: Fax: After Sale service: email : Technical Support: Administration:

(+33)4 67.50.49.00 (+33)4 67.50.49.07 (+33)4 67.50.49.08 [email protected] [email protected]

Additional copies For additional copies of this manual or documentation on other DMS equipments, please write to DMS at the above-mentioned address.

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3 Device description

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STRATOS DR

STRATOS DR is an bonedensitometer using DXA (Dual Energy X-ray Absorptiometry) technology. The system is monitored by a computer equipped with a - minimum – 2.8 Ghz Pentium on Windows XP (or higher). Various locations can be examined such as the spine, the femoral bone, the forearm and the whole body. The source and the detector are mobile in the X and Y directions. The detectors measure the X-ray not absorbed by the tissues and thus provide the density of the measured location. The locations themselves are made up of several parts: Spine: L1, L2, L3, and L4 and Lateral spine BMD Femoral bone: femoral neck, Ward's triangle, trochanter, Intertrochanter, Total Femur Forearm: ultra-distal, mid-radius, distal (1/3) Digital Vertebral Assessment Double Femur Whole body (optional) The software also offers the possibility to compare examinations and to perform paediatric or orthopaedic examinations (optional). STRATOS DR provides the following parameters: Multisite : ƒ BMD (Bone Mineral Density) expressed in g/cm², stands for the density of the bones ƒ BMC (Bone Mineral Content) expressed in g, stands for the dry mass of the bones ƒ Area of the region of interest expressed in cm² ƒ T-Score and Z-Score Whole body : ƒ Total mineral density (BMDt) ƒ Local mineral density (BMDl) ƒ Area ƒ Body composition ƒ Body fatness ƒ Lean body mass ƒ Bone mineral mass ƒ Overall and Regional body composition These parameters are indicated on each area of analysis selected - manually or automatically - on the image obtained by scanning.

STRATOS DR equipment

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4 Warranty conditions

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STRATOS DR

4.1 D.M.S warranty system DMS guarantees that each product sold is free from defects (material or manufacturing defects) and shall conform to its product specifications as defined in the user's manual. If the equipment breaks down during the warranty period, it shall be repaired free of charge or replaced if necessary. 4.2 Warranty Period The period of warranty is stated in the sale contract. 4.3 Warranty limits Misuse, accidental damage, modifications, unsuitable operating environment, or damage caused by a product for which DMS cannot be held responsible for may invalidate the warranty. Items not covered by warranty We do not guarantee: Components and/or equipment not supplied by DMS but which are integral part of the product Manufacturers or suppliers of the mentioned products shall have to provide warranty.

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5 Upkeep

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STRATOS DR

5.1 Upkeep of STRATOS DR: STRATOS DR should be cleaned once a week with a soft cloth and with clean tap water in order to avoid build-up of dust and dirt. NB: Cleaning of the mattress and the cushion may be carried out using a non-abrasive cleaning solution to ensure its cleanliness. To reduce the cleaning requirements of the mattress, it is worthy to consider the use of Disposable Paper Sheets, which can be changed following each patient examination. 5.2 Upkeep of the phantom The phantom should be cleaned once a week with a soft cloth and with clean tap water in order to avoid build-up of dust and dirt.

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6 Maintenance

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6.1 Information There are no user-serviceable parts inside. Contact the authorized service for any required maintenance. A Technical Manual is available on request to the qualified technical staff and authorized by DMS to carry out technical maintenance. 6.2 Preventive Maintenance During preventive maintenance, the unit should be thoroughly inspected, including connecting cables, the printer, the monitor and the software. That also means checking that the used software is adapted to the machine. 6.3 Customer responsibility This product has no particular requirements concerning maintenance/upkeep 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. 6.4 Visual inspection Check STRATOS DR regularly (at least once a month) for exterior damage, including cables, to detect potential damage. Do not attempt to repair or replace damaged parts. Only an authorized representative or a qualified technician of DMS may carry out maintenance or repair work. Should you encounter problems, contact a qualified representative of DMS. 6.5 Electrical Maintenance Apart from the visual inspection of the cables, the user should not carry out any maintenance. Only an authorized representative of DMS shall carry out all operations. 6.6 Mechanical Maintenance Apart from the visual inspection, the user is not allowed to carry out maintenance. If a problem is detected, it should be reported to the authorized representative of DMS. Only an authorized representative of DMS shall carry out all operations. 6.7 Compulsory maintenance The functional maintenance shall be carried out once a year by a representative approved by DMS It shall consist in testing the reliability and the efficiency of the device, as well as in checking it is correctly calibrated and safe. STRATOS DR_anglais_00

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7 Environmental Conditions

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7.1 Information STRATOS DR should be installed in a dry environment and powered by 110/230 V with compulsory grounding. The equipment should be connected to the Ethernet port of the user's PC. 7.2 Conditions of use STRATOS DR should be used within the following conditions: Temperature: 20° - 28°C Humidity: 20% - 80% Pressure: 0.8 – 1.2 bar 7.3 Storage conditions STRATOS DR should be stored within the following conditions: Temperature: 10° - 40°C Humidity: 20% - 80% Failure to comply with the limits could result in inaccurate examination results or in inability to carry out the examination. 7.4 Conditions of carriage (delivery excluded) STRATOS DR is not designed to be moved on large distances (between buildings for instance) or to be subject to shocks. The rollers mounted when the device is delivered must not stay on the STRATOS DR during the use. They are not planned to move the machine once mounted. ∗

An inspection should be carried out each time STRATOS DR is moved.

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8 Symbols & abbreviations

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8.1 Symbols used on the device and its packaging

Type B Equipment: classification according to the degree of protection against electrical shock.

Protective ground.

Keep the equipment in a standing position.

Fragile, Handle with care.

Keep away from humidity and water.

Device approved by the European Community Directive 93/42/EEC – Notified body 0120 Medical classification IIb.

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8.2 Symbols used in this manual

∗ Important read

, > Stop : choice of options Repeat an operation as many times as necessary Hints/Advice for non-beginners

Warning 8.3 Tags The following tags should be applied on the external part of STRATOS DR: 8.3.1 Manufacturer’s tag

8.3.2 Tag signaling X-Ray emission

WARNING X-Ray device : This device may be dangerous to the patient or the operator if the normal conditions of use are not observed.

Estimated Operator Dose at 1m:

Maintenance->import” from the homepage of the software. - Run importation: Select a unit type and specify the parameters if there are. Then click on “Import data” button. The importation will start. It can take few minutes to finish the importation. 13.4.4.2 Review imported examination:

- Find and select imported examination: Go to “Analysis” from the homepage of the software. Then select the patient and the examination you want in the lists. - Print the examination: By clicking on “View scan” button you can see a print out preview of your examination. STRATOS DR_anglais_00

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13.4.5 How to record a paper examination:

13.4.5.1 Create or select a patient:

- Find the functionality Click on the start scan button on the homepage and access the selection patient page. Then, you have two choices - Click on “Add a new patient”. Fill the request fields of the new patient and click on “Add a scan manually”. - Or select a patient and click on “Add scan manually” STRATOS DR_anglais_00

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13.4.5.2 Add a scan manually:

- Fill scan information : Fill both of the tabs to create the examination on the database. In the first tab, you will have the patient and examination general information. In the second tab you will have the results information. Be careful to select the right unit type in the field “Machine type”.

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13.4.5.3 Review the scan:

- Select examination : Go to the analysis page from the homepage and select the examination you have just imported. Then click on the “View scan” button.

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5

Archiving an examination

This chapter describes how to archive the patients examinations on 3 different media (Zip, CD-Rom and DVD). It is preferable that the new examinations be archived at least once a week to avoid hard disk problems. Creating archiving copies enables to free space on the hard disk and thus to store new examinations. This chapter also describes how to restore the archived examinations on the hard disk. A burner and the Nero software (minimum version 5.5.10) are necessary to perform the archiving.

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13.5 Archiving the examinations A burner and the Nero software (minimum version 5.5.10) on Windows XP are required to perform archivings. 13.5.1 Opening the Archiving section: From the homepage of the software go to “Configuration”, select “Archive” and click on “Launch Archiving”:

or on "Yes" if the following message appears: The examinations need to be archived Do you want to proceed now ? Yes No

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13.5.2 Archiving conditions configuration: Once into the archiving section, define the different parameters :

Archiving conditions configuration

To modify archiving conditions, configure each parameter: : Specify the number of examination before next archive. : Specify the number of days without examination archive before next archive. : Specify the number of quality controls before next archive. : Specify the number of days without quality controls archive before next archive. : Specify the minimum requested disk space to archive. : This option is specific to archive on CD/DVD. If you tick this option, the software saves two identical copies on two different CD/DVD.

If you tick this option, the software asks you to validate before archiving examinations. : If you tick this option, the software asks you to validate before archiving quality controls. : If you tick this option, the software archive automatically when you quit. STRATOS DR_anglais_00

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Î

Once configured, click on “Launch Archiving” to start the process.

Example: The following examples show how to configure the software to archive each day or every 100 examinations:

Every day archiving configuration

Every 100 exams archiving example

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13.5.3 Archiving section presentation The following window appears on the screen. It displays the list of patients and of the related examinations:

Examinations archiving window FIELDS “Selection” “Statistics”

“Archives” “Archive” “Restore” “Collapse/Expand all”

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FUNCTIONS To display the selection criteria. To display the examinations by site (in %) according to the selection criteria. To display the examinations by site (in %) on the left part of the screen. To display the place occupied on the hard disk.. To display archives history, to consult, read or restore the archives from the selected media. To archive the selected examinations. To restore a selected examination from the selected media. To display or not the examination details.

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13.5.4 Selecting an archived examination The selection is performed in the same way as described as in the "Data management" chapter. 1

>

Refer to the chapter "How to perform a selection.

1. The "Archiving examinations" section enables the practitioner to choose

the examination he/she wants to archive.

Selection section 2. The practitioner can either select the patient's name or the examination

to archive through three different ways : - Database - Patient data - Examination data

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¾ Click on the pull-down menu and select the database. Then click on "Search" at the bottom of the screen. A list corresponding to the selected database appears on the screen :

Database selection ¾ Click on the fields characterizing the patients and enter part or all of the data (last name and/or first name and/or date of birth and/or sex and/or ethnic group). Click on "Search" at the bottom of the window. ¾ Click on the pull-down menu and select an examination site and/or a date and/or the practitioner's name and/or a machine.Click on "Search" at the bottom of the window. Note : For a selection by date, the practitioner can choose a search performed at the precise date, before the date or after the date.

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3. In the list, click on the patients or on the examinations to archive (the Ctrl key enables to select non-contiguous examinations, the screenshot below shows examinations of the spine and of the forearm that have been selected). Statistical data appear automatically on the right of the screeen :

Examination selection before archiving 4. The selected examinations are tagged according to the statistics by site

(in %) corresponding to the selected criteria. The place they occupy on the reference media is displayed:

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13.5.5 Archiving an examination Run archiving Go to options->archive and click on “Launch archive” button. Then, the database browser appears. You have to select every examination you want to archive before clicking on “Archive” button. N.B.: The archiving can be very long if you have a lot of data. When archiving is finished a spot appears after each archived examination as shown below:

Archived database example

If spots are green, it means that examinations are saved entirely on the local disk and on the archiving media. If spots are orange, it means that examinations are not saved entirely on the local disk and are saved entirely on the archiving media. If spots are red, it means that examinations are not saved on the local disk at all and are saved entirely on the archiving media. The possible actions for each type of data are listed in the array below: Type of archived data

Visualize

Modify

Green

X

X

Orange

X

If archiving media is connected

Red

If archiving media is connected

If archiving media is connected

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To run the archiving at each software closing, just select « Quit and perform » when quitting the software. To end the archiving of the selected examinations, the practitioner should label and identify the media with the reference corresponding to the archiving that has just been performed. This reference shall enable him/her to retrieve the examinations and to view them. Please make sure you have referenced your media, especially if you have several media corresponding to several archives! Referencing convention of the media:

A06PC300_3_1_26/01/2006 Machine serial number

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Archive number

Media number

Archive date

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6

Quality control

This chapter describes the steps to follow to check the precision of the STRATOS DR equipment and the reliability of the measurements already performed. An external phantom is supplied with STRATOS DR.These values are known and referenced in the software. Before the day of use, the practitioner should carry out the test. This chapter describes in details how to make an acquisition of data with the phantom and how to analyze the resulting image. It explains how to access to the quality control file, how to insert the measurement data and how to view both the corresponding data and graph.

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13.6 Quality control 13.6.1 Opening the quality control file Click on “Quality control” in the main menu. This function displays the results of tests made on the external phantom. The results are displayed in form of curves and of graphs that allow the easy identification of a potential problem and of any results deviation with regard to the the ideal results in a delimited period of time. Each point that appears on the graph corresponds to one quality control:

Quality Control window COMMANDS “Control” “Export” “Print” “View” “Print the history“

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FUNCTIONS To perform a quality control. To export the data of the quality control in a CSV or DICOM file. To print the quality control. To review a quality control. To print the graph of quality control.

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13.6.2 Performing a quality control 1. Click on “Quality Control” on the main window:

"Quality Control" button window 2. Remove all the objects from the mattress and click on “Control” and “Validate the site” 3. The arm is moving to the front of the device, at the middle of the mattress, 4. Place the fantom along the front white stripe, the laser beam must point on the edge of the arrow over the fantom:

The laser red point is placed over the edge of the arrow over the fantom.

The fantom is placed along the front white stripe, the serial number sticker is placed in front of the operator

How to position the quality control fantom 5. Validate the positionning by pressing the central button of the keyboard, or by clicking on “Validate” in the software. 6. The Quality Control begins and lasts between 2 and 3 minutes.

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At the end of the Quality Control examination, a global value corresponding to the fantom (including the 3 steps of this fantom) is given. As a rough guide, the individual values corresponding to each step are shown in the windows. The value which is taken into account is the global one for the quality trend: this value is recorded into the “Quality Control Trend window”. Click on “Close” to delete and exit. The following window appears on the screen: Click on “Validate” to access the Quality Control Trend Window. The following window appears on the screen:

Quality control window including the last control

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Click on “Yes”. The quality control data will not be saved NB: If a problem comes up, the following message displays on the screen and it's up to the user to choose to validate or not to validate the performed quality control.

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13.6.3 Viewing previous controls

1. On the graph displayed on the “Quality control” window, select the desired control by clicking on the point, the point turns red and the date of the control appears as follows:

2. Click on “View”at the bottom of the window.

3. The “Quality control” window corresponding to the selected examination is displayed.

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13.6.4 Consulting the quality control results

¾ Selection of the ROI and of the dates:

Graph parameters COMMANDS on the right-hand side of the window “Control” “Average” “Standard deviation” “CV” “Scan date” “BMD value” “Control ”

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FUNCTIONS To display the control of the selected ROI. To display the mean of controls in the given time interval. To display the standard deviation of controls in the given time interval. To display the coefficient of variation of controls in the given time interval. To display the date and the time of the selected control. To display the BMD value of the selected examination Number of controls

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9

Specify the dates between which the measures shall be checked to allow the user to have a more precise view of the specific period.

! The “start date” always displays by default the date of the first examination and the “end date” always corresponds to the date of the latest examination. -

In the “start date” part, enter the date of the beginning of the measures. In the “End date” part, enter the date of the last measure.

The graph representing the measures carried out between the selected dates is displayed.

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¾ Parameters of the graph 1. Click on “Parameters” at the bottom of the window. The following table is displayed:

2. The practitioner may redefine the characteristics of the graph by ticking the following parameters: CURVES “Display the average” “Display the coefficient of variation” “Display the standard deviation” “Display the markers” “Display the lines” “Display the limits” “Display the time axis”

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FUNCTIONS Curve of the data mean. Curve of the variation coefficient at the time of the controls. Curve of positive and negative standard deviations at the time of the controls. To display the construction points of the curve. To display the lines that connect the construction points. To display the authorized limits of the BMD. To display the examinations month after month or by the number of examinations.

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Markers

Mean

Coefficient of variation

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Standard deviation

Line

Limits

Time axis

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¾ Displaying the graph and the selected measures 1.

After validating the quality control and after the possible selection of the graph parameters, the graph is updated.

Quality control window after the last control Acceptable values are located in the area delimited by two dotted red lines. Should a technical problem arise (few points outside the limits, for instance), please contact DMS for assistance.

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13.6.5 Exporting a file

The user may export the quality control data in CSV (text format with separator-character commas) or in DICOM format (in process). 1. Click on “Export” at the bottom of the window:

2. The following dialog boxes are displayed:

3. Enter the file name and click on “save” to save the data.

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13.6.6 Printing the graph and results 1. To print the image on the screen, select “Print” at the bottom of the window:

2. The following message appears on the screen:

3. The practitioner may print the quality control report. It is possible to print the following: - A general report (includes the control report in progres with the graph and the measures for each region of interest). - A detailed report (History report of all the performed controls). - A GRIO report. 4. Click on “general”. The following window appears on the screen:

General report 5. Click on “Detailed”. The following window is displayed:

Detailed report STRATOS DR_anglais_00

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13.6.7 Exiting the quality control file Click on “Quit” at the bottom of the “Quality control” window. The main menu of the software is displayed.

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7

Software configuration

The practitioner shall use this option to gain additional information about the software composition. This part enables him/her to consult, modify or update the parameters installed by default.

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13.7 Software configuration Click on “Software configuration” in the main menu. The following window appears on the screen:

Software configuration window COMMANDS “Database” "DVO" "Archive" “Language ” "Normality curves" "Scan" “Calculation ” “Print” “Institute” “Warm-up and quality control” “Email - DICOM ” “Contact ” "Comments" “Maintenance” “Validate ”

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FUNCTIONS To choose one or several databases. Special specifications. To archive the data. To choose the software language. Normality curves management. Examination parameters. To select the calculation areas. To select the printing parameters. To display the coordinates of the medical institute. To set the warm-up intervals, the full streams and the quality controls. To enter or to modify the parameters of the DICOM. To display the manufacturer's coordinates. Printing comments management. To change the software parameters (must be performed by a qualified technician). To validate the selected parameters

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13.7.1 Database 1. Select “Database” on the list of the left-side of the screen to choose the type of database:

Database window

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13.7.2 Archiving Click on “Archiving” on the left of the screen. A window appears providing information for DMS:

Archiving window

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13.7.3 Language 1. Click on “Language” on the left of the window as follows:

Language selection window 2. Select the language of the software. 3. Validate. All the software data appear instantly in the selected language. 4. Select the Anglo-saxon metric system as follows. 5. Select the format of the date. 6. Select the time format.

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13.7.4 Normality curves Ethnic groups used :

Tick here the default ethnic groups to use.

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13.7.5 Editor of normality curves: 13.7.5.1 Warning:

The editor of the normality curve is a tool dedicated to people who have received scientific training on normality curves. It should on no account be used thoughtlessly because it enables to change the normality curves used as a reference and thus to change the obtained results. 13.7.5.2 Presentation: Access the editor of normality curves by going to Option-> Normality Curve, then by clicking on «Editor of normality curves».

The following window appears:

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13.7.5.3 Description: This text editor is composed of several elements: ¾ One part for the parameters of the curve ¾ One part for the curve values and for the display ¾ Buttons for the creation, deletion, modification and loading of the curve Each part is made up of several elements described below: For the part relating to the curve parameters: ¾ Ethnic group ¾ Existing versions ¾ Date of the last modification ¾ Adjustment factor ¾ Gender ¾ Mode (normal/paediatrics) ¾ Site ¾ Region ¾ Recording version For the part relating to the curve and to the values: ¾ Minimum, maximum age and interval ¾ Indication of the «Peak bone mass» ¾ Value table (MBD and standard deviation) ¾ Operation on the values ¾ Displaying graph of the curve For the part relating to curve management: ¾ Buttons «Create a curve», «Delete a curve», «Save a ROI», and «Erase the table» 13.7.5.4 Creation of a curve: Creation:

To create a new curve, enter a name and to select a reference ethnic group from where the default data are imported. Thus, all the curves of the new ethnic group are the same as those of the reference ethnic group until the latter are modified.

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Curve parameters:

In this section, the user can modify the parameters of the curve on which he works. Note that for each region, an asterisk is in front of the proposed name as long as the region has not been validated.

The adjustment factor helps to import data coming from an external database. This parameter is a corrective parameter enabling to retrieve the same BMD after data import. It is advised not to modify it without receiving adequate training. Curve and values:

This part displays the curve and the values of the ROI that are being modified. The performed operations are only carried out on the selected values. Moreover, if a standard deviation is modified, all the following standard deviations will be modified to the same value. Curve management: The curve management part enables to create a new ethnic group, to delete an ethnic group, to validate a curve or to reset a curve to null value.

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13.7.6 Examination parameters 1 Click on “Scan” in this list on the left of the option window as follows:

2. Then set the different default parameters that can be set for the scan. The parameters which can be set are: ¾ Remember the last user. ¾ Set the visual parameters of the scans (colours of the ROI, …). ¾ Selection of the default curves for the femur.

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13.7.7 Calculation 1. Click on “Calculation” in the list on the left of the window as follows:

Selection of parameters calculation window 2. Select the default areas for the spine calculation: L1 L2 L3 L4 L5. 3. Select the default areas for the femur Trochanter/Neck/Intertrochanter calculation. 4. To save these new parameters, click on “Validate” at the bottom lefthand side of the window.

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13.7.8 Printing 1. Click on “Print”. The following window appears on the screen:

Printing parameters window 2. Tick the desired printing parameters. Click on “Validate”. The selected parameters can be read on the printed report.

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13.7.9 Printing of multiple examinations (more than three): 13.7.9.1 Selection of the examinations:

-

In the window where you can choose the examination to analyze, click on «Print multi-scans»: The selection window of the examinations to be selected displays for the multiple examinations printing.

-

Select three examinations, including a double femur examination: The examinations are displayed in the bottom list corresponding to the examinations to be printed.

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13.7.9.2 Printing report:

- Then click on «Print»: You have a printing report with four examinations.

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13.7.10 Information about the medical institute 1. Click on “Institute” on the left of the screen. The following window is displayed:

Information window on the medical institute 2. Enter the institute coordinates in the fields intended for that use. 3. Click on “Validate”. The data are stored and will be on the printed reports.

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13.7.11 Preheating of the source and quality control

1. Click on “Warm-up and quality control” on the left of the screen. The following window is displayed:

Warm-up window and quality control 2. The practitioner may change the interval for each quality control. 3. Start a preheating of the source.

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13.7.12 E-Mail 1. Click on “E-mail” on the left of the screen. The following window is displayed:

E-mail window 2. Select and modify the E-mail parameters. 3. Click on "Validate".

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13.7.13 Contact 1. Click on “Contact” on the left of the screen. The window provides information about DMS.

Contact window

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13.7.14 Comments Click on “Comments” on the left of the screen. A comments window appears:

Comments window The practitioner may add comments that will be saved. In this section, the practitioner will also find automatic letter editors printed with the print report patients and the doctors. These editors are described below:

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13.7.15 Letter editor (to the patient)

There are two tabs for the two types of letter, ‘Patient letter’ and ‘Doctor letter’. In each the following elements are to be found: ¾ Standard tools for the text edition ¾ Selection of the type of language and of the type of letter ¾ Tag-adding tool corresponding to the variables Standard tools: The standard toolbar is made up of all the traditional elements of a conventional text editor. Selection of the font type, of the formatting (boldface, italics, underline, form, alignment, colour) and adding of tabs. Language and type of letter: The selection of the language and of the type of letter enables to save the various configurations. Letters can indeed be saved in different languages and it is also possible to save letters for each type of diagnosis and of patient (adult, paediatrics, animal). Thus, if the patient is normal, it will be displayed on the printing report corresponding to a normal diagnosis, if the patient is osteopenic, you have the osteopenic letter, if he is osteoporotic, you have the osteoporotic letter. «Tag» tools: This is the most important tool, it enables to add variables in the text. You can for instance add a name and a first name independently of the patient. Thus, for each patient, the field %firstName will be replaced in the printed letter by the first name of the patient. The same will be done with all the tags.

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13.7.16 Letter editor (to the doctor) For the letter to the doctor proceed in the same way as with the letter to the patient, the only difference is that the letter is laid out with the patient parameters and a results table. The text entered into the configuration is added after the parameters and the results table.

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13.7.17 Maintenance The “Maintenance” function shall be mainly used by qualified technicians. 1. Click on '”Maintenance” on the left of the screen to open a file. The following window appears, asking the technician to enter the password:

“Maintenance” window with tab asking to enter password

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13.7.18 Printing on DICOM format The practitioner will use this option (Digital Imaging and Communication in Medicine) to save digital data on any directory (“Export”), or to forward (“Send”) and print (“Print”) them. The configuration of the DICOM network should be carried out by specialized staff. 1. Click on “DICOM” at the bottom of the window 2. The following image is displayed:

DICOM window 3. Then select the parameters window and print. Save the medical report in DICOM format in the desired file by clicking on “Export”. The saved data can only be viewed with a DICOM player.

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Configuration of the parameters in DICOM format The DICOM format: STRATOS DR DICOM is a software and part of the bonedensitometer STRATOS DR with which you can create DICOM files containing all the scan and analysis information in a STRATOS DR report. The created files can be saved on a DICOM server or printed. They can also be saved on the disk and imported later from a DICOM server. The DICOM STRATOS DR uses the TCP/IP protocol of the Windows operating system. The network configuration procedure only concerns trained staff. For further information or for troubleshooting, please contact DMS. Application: The user can select one or several files to save or to print. Save mode In this case, the STRATOS DR report is sent to the DICOM server as an image. Patient information (name, first name, date of birth,...) is also sent. Print Mode: The report is sent to a printer without patient information. A preview of the report is generated to see in advance the final state of the print. This mode can only be used to print directly or to send to a printing server. Worklist mode: “Worklist” request ° Initialize a login with “SCP worklist” as soon as a retrieval request of the “worklist” is performed ° The requests and receptions of information from the worklist are performed thanks to the C-FIND command. -

Patient retrieval request ° Initialization with the HIS SCP selected when the user wants to retrieve an information list on a patient ° The requests and receptions of information from the worklist are performed thanks to the C-FIND command -

Scan retrieval request ° Initialization with the HIS SCP selected when the user wants to retrieve a specific patient scan ° requests and reception are done with C-FIND command.

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Data flow Storage flow:

DICOM Interface

Batch Transfert

SCP for Storage

AE

Print-flow:

DICOM Interface Printer

Batch Transfert

AE

Print Server

Printer

Printer

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“Worklist”flow

Remote Worklist SCP

Modality Worklist SCU

Patient root Query/retrieve SCU

STRATOS DR Application Entity Remote HIS SCP

Study root Query/retrieve SCU

DICOM Standard Interface

SOP specific conformities Save/Print Module Patient

Attribute Name ID Birth Date Sex Age Size Weight Comments Ethnie Address Telephone Country General Study Instance UID Date Time Referring Physician’s Name Doctor’s name Operator’s name ID General Series Modality Instance UID Date Time Number General Equipement Manufacturer Institution name Institution Address Station name STRATOS DR_anglais_00

Default value

Note A

“1” “CR” Note A

Note B “DMS”

Tag 0010,0010 0010,0020 0010,0030 0010,0040 0010,1010 0010,1020 0010,1030 0010,4000 0010,2160 0010,1040 0010,2154 0010,2150 0020,000D 0008,0020 0008,0030 0008,0090 0008,1060 0008,1070 0020,0010 0008,0060 0020,000E 0008,0021 0008,0031 0020,0011 0008,0070 0008,0080 0008,0081 0008,1010 244/275

General Image

Image pixel

Film parameters

Sop Common Notes:

Manfr’s model name Software version Image number Date Time Image comments Samples per pixel Type Number Nomber of frames Photometric interpretation Rows Columns Bits Allocated Bits Stored High Bit Pixel representation Pixel Data Pixel Aspect Ration Window Center Window Width Display Format Film orientation Size Magnification Type Destination Device number Date last calib Time last calib SOP Class UID SOP Instance UID

“1”

Note C “1” “ORIGINAL\\PRIMAR Y” “1” “1” “MONOCHROME2”

Note D Note D Note D “0” “1//1” Note D Note D “Standard\\1,1” Note F Note G “CUBIC” “PROCESSOR”

Note E Note A

0008,1090 0018,1020 0020,0013 0008,0023 0008,0032 0020,4000 0028,0002 0008,0008 0020,0013 0028,0008 0028,0004 0028,0010 0028,0011 0028,0100 0028,0101 0028,0102 0028,0103 7FE0,0010 0028,0034 0028,1050 0028,1051 2010,0010 2010,0040 2010,0050 2010,0060 2000,0040 0018,1000 0018,1200 0018,1201 0008,0016 0008,0018

A: All uidare instances are composed of“1.2.250.30” and of an identifier internal to the scan. B: Internal identifier C: Scan comment entered by the operator or the doctor D:8-, 10- or 12-bit image

Allocated bits Saved bits Bit fort Center of the window Window width

8 bits 8 8 7 128

10 bits 16 10 9 1024

12 bits 16 12 11 2048

256

2048

4096

E :The SOP Class identifier is:”1.2.840.10008.5.1.4.1.1.1” F:Paper orientation is either “landscape” or “portrait” G: Paper size depends on the printer "8IN*10IN” “14IN*17IN”

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“Worklist modality” information model The “Modality Worklist SOP” is a classic model that identifies the various information of the “worklist”. The following entity is defined: Abstract syntax SOP Class SOP Class UID Name Modality 1.2.840.10008.5.1.4.31 Worklist Information Model – FIND

Transfer syntax Name UID List list Explicit 1.2.840.10008.1.2.1 VR Little 1.2.840.10008.1.2.2 Endian 1.2.840.10008.1.2 Explicit VR Big Endian Implicit VR Little Endian

“Worklist” attribute List of the various “worklist” attributes: Description / Module

Tag

Patient Name Patient ID Patient BirthDate Patient Sex Accession Number Patient Address Patient EthnicGroup Patients Comment Patients Size Patients Weight Country Of Residence Medical Alerts Contrast Allergies Study Instance UID Requesting Physician Requested Procedure Description Scheduled Procedure Step Sequence >Modality >Requested Contrast Agent >Scheduled Station AE Title >Scheduled Procedure Step Start Date >Scheduled Procedure Step Start Time >Scheduled Performing Physicians Name >Scheduled Procedure Step Description >Scheduled Procedure Step ID >Scheduled Station Name

(0010,0010) (0010,0020) (0010,0030) (0010,0040) (0008,0050) (0010,1040) (0010,2160) (0010,4000) (0010,1020) (0010,1030) (0010,2150) (0010,2000) (0010,2110) (0020,000d) (0032,1032) (0032,1060) (0040,0100) (0008,0060) (0032,1070) (0040,0001)

Matching key type R R O O O O O O O O O O O O O O R R O R

(0040,0002)

R

As entered by user

(0040,0003)

R

As entered by user

(0040,0006)

R

(0040,0007)

O

(0040,0009) (0040,0010)

O O

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Value As entered by user As entered by user

As entered by user

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>Scheduled Procedure Step Location >Pre-Medication >Comments On The Scheduled Procedure Step Requested Procedure ID Requested Procedure Priority

(0040,0011) (0040,0012)

O O

(0040,0400)

O

(0040,1001) (0040,1003)

O O

Model of the patient's data flow: Abstract syntax SOP Class SOP Class UID Name Patient 1.2.840.10008.5.1.4.1.2.1.1 Root Query / Retrieve Information Model – FIND

Transfer syntax Name UID List list Explicit 1.2.840.10008.1.2.1 VR 1.2.840.10008.1.2.2 1.2.840.10008.1.2 Little Endian Explicit VR Big Endian Implicit VR Little Endian

Patient attribute: List of the various patient attributes. Description / Module Query Retrieve Level Accession Number Patient Name Patient ID Patient BirthDate Patient Sex Patient Address Patient Ethnic Group Patients Comment Patients Size Patients Weight

Matching Tag key type (0008,0052) R R (0008,0050) R (0010,0010) R (0010,0020) (0010,0030) O (0010,0040) O (0010,1040) O (0010,2160) O (0010,4000) O (0010,1020) O (0010,1030) O

Value [PATIENT] As entered user As entered user As entered user

by by by

Model of data flow of a scan Abstract syntax SOP Class SOP Class UID Name STRATOS DR_anglais_00

Transfer syntax Name UID List list 247/275

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Study Root 1.2.840.10008.5.1.4.1.2.2.1 Explicit 1.2.840.10008.1.2.1 Query / VR 1.2.840.10008.1.2.2 Retrieve Little 1.2.840.10008.1.2 Information Endian Model – Explicit FIND VR Big Endian Implicit VR Little Endian Scan attribute: List of the various scan attributes: Description / Matching key Value Model Tag type Query Retrieve R [STUDY] Level (0008,0052) R As entered Study Date (0008,0020) by user R As entered Study Time (0008,0030) by user Accession R Number (0008,0050) R As entered Patient Name (0010,0010) by user R As entered Patient ID (0010,0020) by user R As entered Study ID (0020,0010) by user R As entered Study Instance (0020,000D) by user Patient O (0010,0030) BirthDate Patient Sex (0010,0040) O Patient Address (0010,1040) O Patient Ethnic O Group (0010,2160) Patients O Comment (0010,4000) Patients Size (0010,1020) O Patients Weight (0010,1030) O

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13.7.19 Configuration parameters For each DATA BACKUP, PRINTING and WORKLIST request, the following elements can be configured: - STRATOS DR AE Title (Name of the STRATOS DR in the DICOM network) - AE Title Server (Name of the server in the DICOM network) - IP Address Server (Server address in the DICOM network) - Port number Server (Used port) These parameters must be configured in the option menu->Email – DICOM of the STRATOS DR software.

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13.8 Exiting the program 1. Click on “Quit” at the bottom on the right of the main screen.

2.

Click on “OK” to confirm.

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14 Patient information

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PATIENT INFORMATION Bone treatment, osteoporosis and you What is the STRATOS DR principle of measurement? STRATOS DR is an Bonedensitometer using DXA (Dual Energy X-ray Absorptiometry) technology. It is monitored by a - minimum – 2.8 GHz Pentium computer running under Windows XP (or higher). The analyzes may be carried out on the spine, the femur and the forearm. The X-ray source emits a beam of energy, which is then divided into 2 energies for the data processing on the detector. Measuring the X-ray not absorbed by the air, by the soft tissues and the bones allows the software to provide the density of the measured location. STRATOS DR provides: • BMD (Mineral Bone Density) expressed in g/cm²; it represents the bone density. • BMC (Bone Mineral Content) expressed in g; it represents the bone dry mass. These parameters are indicated for each analyzed surface (automatically or manually) on the image obtained by the scanner. Why use X-ray ? The different measurement techniques of bone density by X-ray have an advantage: they are interpreted in terms of photon interaction with material. Absorptiometry by an X-ray double beam has replaced dual emission absorptiometry with radioisotopic source. It uses an X-ray tube that dates back to the seventies at the time of the X-ray spectrometer. This technique improves the performance of bonedensitometers by combining photons of the highest energy with smaller sources. The use of a narrow and intense radiation beam has shortened scanning time, improved image definition, and sharpened precision. Reproducibility in hospital use is another advantage of DXA. Why measure the spine, the femur or the forearm? DXA studies of whole bodies provide comprehensive information on the bone density of the whole body, its mineral content and the composition of soft tissues. However, the spine, the femur and the forearm are still considered as the most important measurement regions: these sites are frequently subject to osteoporotic fractures that considerably alter quality of life and can cause morbidity and mortality. Is there a potential danger during the examinations? Clinicians and technicians that prescribe and carry out the scans should be informed that any exposure to ionizing radiations is risky. However, studies on patients exposure to radiations by DXA scanners have confirmed that the level of doses was low compared with that of radiological technologies. During diagnostic procedures the levels are so low – particularly for studies on bone densitometry – that the dose the operator receives with STRATOS DR_anglais_00

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beam scanning systems is sometimes difficult to detect and to measure properly. Cancers and potential genetic pathologies of the new-born whose mother has been subject to exposure during her pregnancy are inherent risks.The risks are comparable to the risk of death in a plane crash: it depends on chance and rises according to exposure (to radiations). It is however not easy to measure scientifically the risks associated with radiations. Risks taken on a daily basis which are comparable with the risks taken when someone undergo a DXA study, are listed on the following table: Here are a few activities with a death hazard comparable to the risk run after an efficient dosis of 1µSv during a DXA examination (Pochin data) Exposure to a radiation of natural origin for 4 hours. Smoking the tenth of a cigarette. Covering 5 kms by plane. Etc. What is the T-Score? The T-Score represents the deviation between your value and the mean value of a healthy young person of your sex and your ethnic group. If your T-score is higher than -1, you are considered “normal”. If your T-score is between -1 and -2.5, you are osteopenic, which means you have a low bone mass. It is not osteoporosis yet, but you should consider a treatment and/or changing your diet habits and practicing more physical activities. If your T-score is lower than -2.5, you have osteoporosis. What is the Z-score ? The Z-score represents the deviation between your value te and the mean value of a group of healthy subjects of the same age. For young subjects between 20 and 40 for instance, there is no considerable difference between the Z-score and the T-score. However, the bone density decreases for older patients, a decreasing T-score is therefore normal. The Z-score is thus useful to determine if the decresase in bone density of an elder patient is due to the normal decrease of bone density because of age if the Z-score is close to 0, or if the risk of fracture runs high (in this case, the Zscore is negative). How reliable are the results? The purpose of using physical measures in clinical studies is to ensure both coherent and quality data. The measurements of X-ray dual emission absorptiometry (DXA) are the current standards accepted to measure bone density. Indeed, this method is known for its high precision, its low radiation doses and its calibration stability on the long run. It is for that matter the DXA technology is widely used for testing new medicines to prevent bone loss or osteoporosis treatment. STRATOS DR_anglais_00

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For DXA, the precision of a device is determined after daily examinations on phantoms which enable to measure regularly the coefficient of variation of the machine. A critical aspect of quality is to make sure that precisely the same anatomical region of the patient is scanned each time the patient undergoes an examination.The examination should be analyzed accordingly in the same way by selecting an identical region of interest. What you need to know about osteoporosis? Osteoporosis is a disease that wears out and weakens your bones, exposing you more to fractures even through minor shocks, blows or falls. People who have osteoporosis suffer more often from fractures of the spine, of the hip or of the wrist. Roughly 25 million people are affected by this disease called the “silence disease” and most of them do not even know about their condition until a fracture occurs. Even if osteoporosis is a considerable health problem for many people in the world, it is particularly common among women in their fifties. One woman upon three or one man upon five aged 50 will suffer from a fracture due to osteoporosis in his/her life. What causes osteoporosis? Your bones are made of living tissue. You may not know it, but your bones change constantly. They wear out and rebuild at the same time, and these ongoing activities are called "reshaping". During the teenage years till the early twenty, the “reconstruction” dominates, and the bones are stronger and stronger. At the age of about thirty or fourty both activities balance each other more or less, and your bones are stronger than ever. The maximum strength of the bones depends on many factors, including genetics, hygiene (nutrition and physical exercise), medication and chronic diseases. After 40, the “erosion” becomes dominant and time weakens your bones progressively. Theoretically, there is no need to worry – reshaping is part of the natural cycle of life for all of us. However, you may develop osteoporosis if the reconstruction of the bone slows down early or if “erosion” speeds up or both. With osteoporosis, your bones are weaker than the bones of the people of your age and you tend to have fractures more frequently. Who is subject to osteoporosis ? A post-menopause woman is very likely to belong to the group of people affected by osteoporosis. When menopause occurs, your body reduces the production of an important hormone called oestrogen. This hormone is important during the reproducing years and it helps you keep your bones strong. There are other risk factors that may lead to osteoporosis. They include family history with osteoporosis, a frail body frame, alcohol consumption, cigarettes, STRATOS DR_anglais_00

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a lack of physical exercise, the long-term use of drugs such as corticosteroids, and early menopause. Are you susceptible to osteoporosis ? The first person you should contact is your doctor. He or she will review your medical history and if there are grounds for worry about osteoporosis, he/she can advise you to have a bone assessment. The examination results, combined with your medical history, shall help your doctor to determine if you have or can develop osteoporosis. What kind of bone analysis is it? Until the seventies and the eighties, the best way to have your bones checked was to have your hip or your spine X-rayed. A skilled radiologist could analyze the X-ray and identify your bones condition. Unfortunately weak bones are only visible when damaged and partially destroyed. This type of examination is not efficient as “prevention system”, it would be ill-advised to expose patients to useless X-ray radiations. Better and safer methods have been developed to enable earlier and more efficient bone examination. In the seventies and in the eighties, specific radiological examinations were developed to help detect osteoporosis at an earlier stage. These examinations are called “bone mineral density tests” (BMD). The BMD is the most widespread method to check the health of bones. Measuring it allows the doctor to determine the bone quantity at a given location of your body, it is called bone density. The lower is the density, the weaker is your bone, and it’s more likely that you will have a bone fracture. This kind of measure can be carried out on various locations such as the spine, the femur, the arms and the legs. The BMD measures also imply X-ray radiations but at lower levels than traditional X-ray. In 1997, a new technology for bones examinations approved by the “Food and Drugs Administration” (FDA) in the US. This new method, called “Bone sonometry” is similar to the method used by doctors for the follow-up of a pregnant woman and of the foetus, it is based on ultrasounds. BMD and bone sonometry are not always used on the same locations of the body and the test results are not always identical. Each technology has a welldefined body area of measurement. Nevertheless, as osteoporosis is a generalized disease, affecting the whole skeleton, it can be detected on various parts of the body. Your doctor knows how to interpret the results and with his help, you can take steps to improve your health on the basis of facts. What should the patient avoid to wear? The main factors that may interfere during the examination are metallic objects such as belt buckles, coins, a corset, an underwire bra and the zippers. The patient should remember to take them off. How long does an examination last? STRATOS DR_anglais_00

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Examination time depends on the time it takes to search the patient's file in the database, plus the scanning time itself. In theory, a scan lasts: • Spine: Less than 1 min • Femur: Less than 1 min • Forearm: Less than 1 min • Whole body: About 4 min Results and interpretation 1. The higher is the density, the healthier are the bones. 2. Your bones are compared with the bones of a typical person of the same sex and are indicated in a unit of measurement called “T-score”. 3. Your results are also compared with those of a typical person of your age and of your sex and are indicated in a unit of measurement called “Zscore”. All the information are then printed on a report showing the scanned image of your bones, as well as the results. Your doctor knows how to interpret the numbers and the results and can discuss with you what they mean. What can you do with your results? Your doctor tells you what is the best to do. If your examination results are weak, he/she'll probably suggest you take preventive steps (such as an increase of calcium and/or D vitamin consumption to prevent bone mass weakness) and/or he/she'll prescribe the appropriate medicine (such as oestrogenic treatment). The time that the doctor will need to treat you depends on a variety of factors. But you can act on a daily basis for your health : ƒ ƒ

ƒ

ƒ

Through healthy nutrition By making sure your diet includes enough calcium and D vitamin (critical to build strong bones, for instance in dairy products, barb fish such as sardines, etc..). By doing physical exercise during which you “"bear your weight” (your body supports its own weight, for instance walking, jogging, aerobics). Swimming is an excellent exercise for your joints but not the best option to strengthen your bones By avoiding alcohol and tobacco consumption.

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15 Troubleshooting ∗

Should any of the following problems arise, please contact our customer service.

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15.1 During the automatic calibration 15.1.1 The X-Ray counts are very slow (0, 1, 2, 3, …) 1) No X-ray emission ⇒ Switch STRATOS DR off and switch it on again a few seconds later. 15.1.2 Error message: baseline adjustment There are two kinds of problems: 1) The result of the previous calibration and the result of the installation reference differ quite. Try to redo the examination. If the problem remains and a variation of reference counts has been observed during the starting phase of an examination, if no object was between the X-Ray source and the detector: If the difference between HE and HEref is over 15%, please contact the After Sales Service. If the difference is below 15%, click on “Remake reference counts” 2) If the patient leaves his/her arm between the X-ray source and the detector during automatic calibration. ⇒ Ask the patient to put his/her arm behind his/her head and start the calibration again.

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15.2 During scanning 15.2.1 Poor image quality

⇒ If the image is distorted, the machine has a problem and the user should contact a DMS representative for advice. ∗ Please note that if the image moves slightly, it is certainly because the patient moved during the examination. You need to ask him/her. If the answer is yes, you must start the examination again as many times as necessary without however exceeding the maximum yearly doses prescribed for X-ray. 15.2.2 The signal lamp is off

⇒ Check that the power cable of the machine is plugged to a ~110/230 Volt and 50/60 Hz input. ⇒ Check that the power outlet supplies the correct voltage to the machine. 15.2.3 The scanner’s arm does not move

⇒ Check that the device is switched on ⇒ Make sure the machine is connected to the computer and that you didn't forget the interconnection cable. 15.2.4 No X-Ray emitted

⇒ If the scanner is on but if there are no X-ray emission, check that the scanner is connected to the computer. 15.2.5 The control panel does not work

⇒ Check that you are working in remote control mode.

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16 General specifications

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16.1 Declaration of compliance with international standards The device is in compliance with the following regulations:

• • • • • • • •

IEC IEC IEC IEC IEC IEC IEC IEC

60601-1 60601-1-1 60601-1-2 60601-1-3 60601-1-4 60601-1-6 60601-2-7 60601-2-32

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16.2 Exposure level to X-Ray Patient dose (roughly in the standard working conditions) Contact DMS to know the measuring protocols of the patient dose and the test reports of the studies that have been carried out. Typically, the maximum skin entrance dose is 45µGy (Spine mode) Operator dose : Distance operator-device 1m

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16.3 Accessories specifications ! Only use accessory/peripheral devices complying with the IEC standards 16.3.1 The computer Specifications for a minimum configuration: • CPU Intel Pentium (2.8Ghz minimum) • 512Mo RAM • Hard disk: 60Go minimum • 15” or 17” LCD screen • CD-DVD burner • Color printer 16.3.2 The screen Screen specifications : • 15”or 17” SVGA (or larger) • EC approved • 800x600 minimum resolution 16.3.3 The printer Printer specifications: • Hewlett Packard 690 • Epson Stylus • Any other printer compatible with Windows XP or Vista

16.4 Operating conditions • •

Temperature 20° - 28° C Relative humidity 20 - 80%.(no condensation)

16.5 Communication •

Ethernet cable from the user PC to the device

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16.6 Fuses The internal fuses of the device are defined as follows:

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16.7 Mechanical data Dimensions: • During transportation (packed) Contact DMS to know the packaging of the device. • During operation (unpacked) 240 cm (L) x 125 cm (W) x 145 cm (H) Weight: • 250 kg

16.8 Layout requirements Recommendations to fulfil the layout requirements:

Premises layout

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16.9 Environmental conditions of storage and of transportation • • •

Temperature: -10°C to +50°C (-14°F to +117°F) Humidity: 10% to 90% RH (no condensation) Pressure: 700 mBar – 1060 mBar

16.10 Limits and specification of the clinical parameters Limit of the clinical parameters - Bone Mineral Density (BMD): 0.3 – 1.4 - Age grouping: 15 – 95 years old (Statistical data exist for this age grouping, however the lack of statistical data does not mean the patients examinations can't be outside this age grouping) Weight < 150kg (Desirable limit based on the available space for the patient between the patient and the X-ray detector and the mattress). Specification of the clinical data Bone mineral density (BMD): +/- 1.0% in vivo (+/- 0.5% in vitro).

16.11 Data sheet of the X-ray system 16.11.1 X-Ray monoblock Manufacturer Tube model Maximum operating condition of the tube Focal point dimension Inherent filtering Physical filtering

PSM OX/110-5 PHU 100 kVolt 2.0 mA max. 0.6 mm x 0.6 mm 1.4 mm Al at 75kV 200 µm samarium 2 mm aluminium

16.11.2 Collimator Materials: Height: Collimator diameter: Collimator-patient distance: Tube – patient distance: Operator radiation level: Shutter: STRATOS DR_anglais_00

Lead and brass 5 mm 1 and 2 mm 50 mm 160 mm