Home

user guide

1. A e ie iO deg at max Ran JA Other Ipa a at max MI information W cm Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 45 sur 104 BECM Probe model C360R Mode B Do TS HR Lassa ns NM Maximum Index Value CS AS SS E L Min Pa zs lta a zs zatmaxlpiacm__ ___s___ Qd degbo em 1 JM q Associated fawW MHz La Lan 1 412 a acoustic DimAaptX QI a qd ll q a parameters AA ON O E E dus lo 4 q q erz 1 32 J J B J c l y O pratmaxlp LL 478 1 0 deg at max pi cm Y information W cm 106 E A Probe model C360R Mode CFM A Dus emer Index label praia MM CP o 22 J MinPazs taazs zsm PE RE E G EC gt zom PE E E G zaimaxipiacm BT deg em 1 TT Associated fawMHz_______ 354 341354 LIT y acoustic Dim Aepg X 0 2t ei parameters Y S o fT dus o8 0 9 0 _ _ prtz Is 1 EE E e A E O deg at max bon IT Other Ipa a at max MI information Rem 4 E EEE Dolo o o EA ooo S Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 46 sur 104 BECM Probe model C360R Mode PW Do TS HR Non scan SS a e ds ea Do LE O e a O zsm ES E pem RER REEL o T m o 0 o T es o amaron o TO sa Associated Dat NHS on o os a acoustic
2. Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 4 sur 104 BECM 2 Safety instructions 2 1 Safety instructions for ultrasound equipment 2 1 1 User profile A Warning This equipment must be used only by a user trained to the ultrasound imaging technique This training allows the understanding of displayed ultrasound images the understanding of how to perform measurements on images or on Doppler spectrums The user must have read the complete user s manual in order to know the instructions needed to operate the equipment He must refer to the user s manual at any time in case of doubt about the use of the device A Warning It is mandatory to read the user s manual before starting an examination People which are not trained to ultrasound diagnostic imaging technique must not use the Exago equipment 2 1 2 Acoustic power The AlUM American institute of Ultrasound in Medicine has stated on the use of ultrasound for medical diagnostic that no confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound equipments have ever been reported Although the possibility exists that such biological effects may be identified in the future current data indicate that the benefit to patients of the safe use of diagnostic ultrasound outweigh the risks if any that may be present The institute indicates that the benefits of a safe use of
3. CD MA Manuel utilisateur Exago 1 10 EN Page 42 sur 104 BECM Probe model C360V Mode PW Index label p Pmw 1 oa fo a Min Pa zs taaz E ep RR Iz om 28 zbo cm 28 Iz cm Y 6 z at max Ipi a em 6 ooo deqzb cm RSEN Associated EE SER n O O RE A acoustic Dim Aaprt_X 2 sl Y parameters pari II fff deg at max Ip om Ipa a at max MI information Wiem Probe model C360V Mode M E ME CS EM MEE E RT pama f 18 Pf Mm LD al inata Pp o pa pp sm Pg po o xp em o o o fes fo po pm pp pe ps po z atmax pi a em 6 Pp PO pp deqb om O H o o fo po Associated wmz 25 cao 24 o acoustic Dmaanx 1 a a dy parameters o DE ll Fe e a uus Y as op pp EE EE E E So EE Other Ipa a at max MI information Rem Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 43 sur 104 BECM Mode B Probe model C360A mode 2D po mom Non scan Maximum Index vals oss 04 He pf et fff aa IPmw EO Iz com zop em bem amapan 8 deq zb c AAA MAA yo h Associated ege E O O ES acoustic Dm Aet X _ za Y A Y A parameters ooo FE pr at max pi O l l S deg at max Ip om JA Ipa a at max MI information W cm Probe model C360A Mode CFM Do ms TJ EE Ind
4. 10 EN Page 10 sur 104 BECM Portable communication equipments can affect the normal function of the equipment refer to table 6 of annex II A Warning The equipment should not be used close to other equipments and if it is not possible to do differently the functioning of the Exago device should be monitored in order to check that it is working normally 2 7 Probe and equipment compatibility The probes supplied with the Exago equipment are intended to be used only with this system N Warning Never try to connect the supplied probes to any other ultrasound system This can lead to irreversible damage on the probe connector and to the possibility of much higher acoustic output than required This can also lead to patient burn due to overheating of the probe The Exago device is designed to be used exclusively with probes supplied by ECM together with the device N Warning Never try to connect a probe to the Exago device which is not supplied by ECM and described to fit the Exago equipment This can lead to irreversible damage on the Exago probe connector and to the possibility of much higher acoustic output than required This can also lead to patient burn due to overheating of the probe N Warning Check the cleanliness of the probes before starting an examination Also check the probe in order to detect any shock crack or damage on the casing and the acoustic lens Never use a damaged probe for an examination N Wa
5. Computer assisted analysis of multiple fetal growth parameters B CFM Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements British Journal of Obstetrics 8 Gynaecology jan 1994 vol 101 P B CFM Chitty 35 43 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and Transverse Abdominal INSERM U 155 Diameter B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 Thoracic diameter B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Fetal Aorta PI Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Li Mai Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Le
6. Fetal Aorta RI Schaffer Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z Mai Geburish u Perinat P 221 222 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Left Uterine PI Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Left Uterine RI Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Right Uterine PI Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 58 sur 104 BECM H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Right Uterine RI FG PW Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Le Mai Geburish u Perinat P 221 222 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalw
7. The operating Focus is displayed on screen by a triangular marker on the depth scale Same key is used to exit the Focus selection menu If no contextual keys are used for 15 seconds the system automatically exits the Focus menu If the option Tools Circular selection Focus amp Frequency in the Setting menu is active the Focus button automatically brings the focus from one step to the next in a circular way 19 Probe access to Probe selection if system used on dual port trolley and to Preset menu for factory and user defined preset selection This key is only active when in live imaging If image is frozen press Freeze to access this menu Probe contextual menu includes e Probe 2 Only active if the device is used on dual port trolley e Probe 1 this contextual key displays the connected probe identification for example L738P e Preset access the Preset selection menu This menu displays a Factory Preset list and a User Preset list o Load load the selected Preset o New save the current system settings into a user Preset file Enter a file name in the Save as field and press the Enter key The new user Preset is listed in the User Preset list o Rename rename the selected User Preset Enter a file name in the Rename as field and press the Enter key The new user Preset is listed in the User Preset list o Delete delete the selected User Preset Factory Presets cannot be renamed or deleted o Exit exit the Preset menu
8. dampedi in a solution of mild soap and water 4 Follow carefully instructions for low level disinfection indicated by the disinfectant manufacturer 5 Remove any cleaning solution residue with a clean soft cloth dampedi in sterile water 6 Air dry or dry with a soft clean and dry cloth N WARNING Before proceeding to any cleaning of the equipment check that the system is switched off and all electrical connections and peripherals are unplugged N WARNING Do not use alcohol or other strong chemicals agents that may damage the casings of the equipment Do not poor or spray liquids directly on the equipment 7 2 Cleaning and disinfection of probes 7 2 1 External probes External probes have a low infection risk This risk level corresponds to the use of so called non critical medical devices which means devices which are not in direct contact with the patient or which are in contact with intact skin The needed treatment for this type of medical device is a low level disinfection especially bactericidal Low level disinfection procedure The probes supplied with the Exago device must be used only on intact skin The following disinfection solutions have been tested and their compatibility with the components of the probes has been proved Alkazyme Klenzyme Cidezyme Nu Cidex Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 31 sur 104 BECM Anioxyde Gigasept FF Ster
9. 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 72 sur 104 BECM CRL Tokyo FG Age Tay Ty Tend E 20 137 E 264 FL CFEF FG Dime o 4 H H A A Duma a o o o o Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 73 sur 104 BECM FL Chitty FG EE IE NEN Td ESL M 75 40 10 E 13 En 165 BE 7 RA Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 74 sur 104 BECM FL Hadlock FG age E we DES m 77 350 n E 143 EN Us Do o SE E ATT FL Hansmann Identical 50 ram Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 75 sur 104 BECM FL Osaka Identical nan 25D FL Tokyo FG AAA Peo RR Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 76 sur 104 BECM FTA Osaka Identical EE sh Cd SC 77 73 ARO Do Y E589 0 o T o o GS Hansmann Er w days 5 5 GS Tokyo FG SR 36 8 7 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 77 sur 104 BECM GS Rempen FG 4 09 O no ns AR 70 8 HA Chitty FG A 3 cm 50 cm 97 cm Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 78 sur 104 BEC HC CFEF FG HC Chitty drvd RSR 20 0 Version 1 du 03 05 2013 M 3 mm 05 8 18 7 43 0 54 5 65 4 86 3 96 2 FG 3
10. 618 _ ____ ____ ____ _ y acoustic DmAapt X S 106 ___ ___ Z y parameters Y 1 To J 0 1 y dus ES EE iprHz 84 pg 0 0 TE IE E L Ed O O O gt deg at max pr cm JA Other Ipa a at max MI information O Probe model C614P Mode CFM E M MME UR n I Sm pmw TC ma a MinPa zs ltaa zs III oo o Iz em 1 O O 1 zoem LL q q a Izbem 1 q dd q II zatmaxpiacm 3 1 0 deq zb cm m HL i Associated faw MHz 613 630613 o S a acoustic DimAapt X me 1 S a parameters YES III a dus oq dl q poo 5 prtz qa To q q 1 O pratmaxipi 242 q degatmaxl em So d information W cm 56 A 4 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 54 sur 104 BECM Probe model C614P Mode PW miS TB On sean _ po Gebees IR EE epg 3 2489 9 Min Pa zs tta a zs pasea AA LL LG em RT IEA TE IS IE E zen AO poa pp zatmaxipiacm 3 1 1 YH Associated fawMHz_______ 616 2 J 68 oe _ al acoustic DmAapt X 10 Z9Gdo 100 a parameters ge E E 318 148 Idus 1485 o o lpgrHz 9020 Jo 0p _ deg at max pr cm JA Other Ipa a at max MI information Wiem Probe model C614P Mode M
11. B to exit Dual mode e L R U D invert displayed image orientation Left Right or Up Down A round dot on display indicates probe element n 1 e Frame Average select frame averaging level among SLOW SLMED MFAST FAST values Displayed temporarily on screen with FAvg label e Noise Reject activate the Noise Reject window on the screen The window position can be adjusted by the touchpad control After pressing Select the window size can be adjusted by the touchpad control The Noise Reject level 0 15 is displayed in the window and can be adjusted by pressing the and contextual Noise Reject keys All signals below the selected level will be filtered to provide a cleaner image Press Clear to exit e Biopsy activate the display of biopsy needle guiding channel on the screen The needle channel is shown with two dotted lines within which the needle should travel Before using this feature it is recommended to test this function in a water tank before use on a patient The mechanical tolerances of the biopsy guide may exceed the expected values and the guiding channel is purely indicative Press Biopsy or Clear to remove the Biopsy guiding channel display gt Warning This biopsy needle guide is only valid if the operator uses the biopsy guide recommended by ECM and listed for each probe See chapter 2 8 gt Warning The user must check that the biopsy guide is properly attached to the probe to ensure secure guidan
12. Exago memory es The arrow upwards indicates storage on a USB stick The arrow towards the right indicates a storage on the Dicom server Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 29 sur 104 BECM 6 Connection of peripherals The Exago equipment can be connected to several peripherals like composite video printers USB peripherals flash stick External screen DVI connection To ensure the electrical safety of the equipment N WARNING All peripherals requiring a power input printers monitors etc must also use a medical isolation transformer or comply themselves with the electrical safety standard EN 60601 1 Otherwise the patient electrical safety is no longer ensured N WARNING To ensure the electrical safety of the device never touch any parts of an electrical non medical device situated in the patient s environment at the same time as the patient To ensure the electromagnetic compatibility of the equipment N WARNING This equipment is intended to be used only by health professionals This equipment can cause electromagnetic perturbations and alter the behavior of another equipment It may be needed to move the equipment or change his orientation in order to reduce this perturbation Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 30 sur 104 BECM 7 Cleaning and disinfection instructions The protection of patients and staff fro
13. If no contextual keys are used for 15 seconds the system automatically exits the Probe menu 20 Zoom display Zoom box on image and access Zoom menu The ROI position can be agjusted by the touchpad control Select Zoom scale factor x1 5 x2 x3 using contextual keys and press Select to display zoomed image Zoom scale factor is displayed on screen label Zoom Same key is used to exit the Zoom menu and to get back to normal non zoomed image If no contextual keys are used for 15 seconds the system automatically exits the Zoom menu 21 TGC access to TGC menu For every image depth the TGC can be adjusted at 4 different levels within the current image depth corresponding to the blue dots on the curve Adjust TGC levels using the and contextual keys The active level is highlighted on the TGC curve in yellow during the modification The currently used value from 12 to 120 is displayed on each of the 4 contextual menu Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 23 sur 104 BECM keys Press Reset to return to initial TGC level Press TGC again to exit the TGC menu If no contextual keys are used for 15 seconds the system automatically exits the TGC menu 22 Clear clear all annotations arrows from current image Clear Biopsy guide and Noise Reject from current image 23 Settings access to the Settings menu This menu is made of 3 folders and 3 functions from the contextual menu Use
14. MHz field strengths should be less than 3 V m Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 40 sur 104 BECM TABLE 6 Recommended separation distances between portable and mobile RF communications equipment and the Exago equipment The Exago equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Exago equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Exago equipment as recommended below according to the maximum output power of the communication equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz ld ATP d inJP da P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply i
15. Manuel utilisateur Exago 1_10 EN Page 8 sur 104 BECM The probes are the only Applied parts of the Exago system No other part of the equipment is intended to be in contact with the patient A Warning Always inspect the probe head housing cable and power cord before use see section 2 8 probe information Any crack or damage to the probe head can lead to electrical shock Never use a probe that is damaged that has been dropped or has been suffering a severe shock until it has been inspected by an ECM customer service engineer N Warning Do not soak the transducer connector in any liquid Soaking it can destroy its electrical safety features N Warning Always disconnect the system prior to cleaning Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 9 sur 104 BECM 2 5 Patient environment The Exago ultrasound scanner is designed to be used in an environment as defined on the figure below 25m 1 15m 2 6 Electromagnetic compatibility The Exago ultrasound scanner is compliant with the standard EN 60601 1 2 concerning electromagnetic compatibility EMC A Warning The Exago ultrasound scanner is a medical electrical device which needs special care regarding the EMC The equipment should be installed and started by a trained person according to the detailed information in this manual refer to annex II N Warning Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1
16. SA Dvs M T L Dm 788 Le 7 Dm 0 75 o o Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 84 sur 104 BECM THD Hansmann Identical Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 85 sur 104 BECM Fetal Ao RI Schaffer FG 577 A 077 98 L 22004 077 Do 98 9 29103 077 CL CL Dos Y E 2608 YA Dimas 0 07 98M 9 nos 07 A Do 0 07 98M E Dimas 0 o 68 9 F3 0 99 E nos 0 98M 9 E5493 0 98 E sms 0 o o R 978 98 E Fetal Ao PI Mai FG Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 86 sur 104 BECM Fetal Ao PI Schaffer FG w afafa n ln lnl sll llla E ES RCA RCI Ko Ko N a EAN ES lela a O wm K o N N Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Ln Page 87 sur 104 BECM MCA PI Mai FG os L N sO a LA da e Sai Keo Keo Ren Wi Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 88 sur 104 BECM ame A A RI Schaffer FG es A PI Mai FG 7 Version 1 du 03 05 2013 R f C
17. adjustment Select is used to return to M mode display CFM in operating CFM Mode return to CFM Pre trace mode Position Size Steering After adjustment Select is used to return to CFM mode display PW in operating PN Mode freeze PW display and return to live operation of B mode for PW gate adjustment by Touchpad and PW Pre trace menu Gate Size Steering Angle After adjustment Select is used to return to PW mode display When the PW is activated in B CFM mode pressing the update button returns to the B CFM mode with the PW gate displayed 8 Cineloop freeze the system if operating live and access Cineloop menu Play and pause the sequence of stored images from the Cineloop menu Cineloop contextual menu includes e First Image set current image to first frame in Cineloop memory Index of current image is displayed on screen e Play Pause play pause the sequence of stored images from the Cineloop memory Last Image set current image to last frame in Cineloop memory Index of current image is displayed on screen e StoreClip Store current clip on external USB device if any or in internal memory 9 Touchpad pointing device used for menu selection measurement cursors validation of measurements etc 10 Select used to confirm selection of items to activate Active CFM mode Active PW mode and M mode to go from one calliper to another in measurement mode to activate measurement cursors to display zoomed image to swi
18. are disposable 2 8 2 Inspection of probes N Warning Before each use inspect the transducer lens case and cable Check for cracks or other damages that may allow liquids to enter the transducer If you find any damage do not use the probe until it has been inspected and either repaired or replaced by an authorized ECM customer service engineer Warning Any crack or damage to the probe head can lead to electrical shock Never use a probe that is damaged that has been dropped or has been suffering a severe collision until it has been inspected by an ECM customer service engineer In case of failure or replacement of a probe the damaged probe must be recycled Take care of bringing the probe to a certified recycling center or return it to the distributor The distributor s address is found on the first page of this manual Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 12 sur 104 BECM 2 8 3 Handling of probes A Warning The probe is fragile and requires proper handling care and cleaning Transducer care includes daily inspections cleaning and disinfections between each patient Please refer to chapter 7 2 about how to perform proper care to the probe A Warning Always place the probe in the probe holder placed on the trolley or in another secured place when not used on a trolley in order to avoid it from falling either on the patient or on the floor Any crack or damage to the probe he
19. components but not for their efficiency in producing the required level of disinfection For information about the efficiency of each solution please consult the respective disinfectant manufacturer A WARNING Do not soak the probe in a solution any longer than the disinfection agent manufacturer s recommendation Follow the disinfection agent manufacturer s recommendations for disinfection N WARNING Do not rub the probe with an abrasive sponge Use a soft cloth or towel WARNING The following procedures are known to damage transducers They can damage both the electrical safety features and the acoustic performance of the probes Do not use the following procedures Gas sterilization Ultraviolet sterilization Dry heat sterilization Autoclaving Soaking a transducer in a chlorine bleach solution 7 3 Submerging limits N WARNING During cleaning and disinfection of probes take care of never exceeding the submerging limits indicated on the following figures Probe C360V C360A C360R Submerging limit in a fluid Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 33 sur 104 BECM Probe L738P Submerging limit in a fluid Probe C320A C614P Submerging limit in a fluid NA Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 34 sur 104 BECM Probe E610A E610R Submerging limit in a fluid Version 1 du 03 05 2013 R f CD MA Manu
20. device is running or not While the battery is charging a charging indicator is visible on the back panel of the device yellow lea Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 16 sur 104 BECM Version 1 du 03 05 2013 R f CD MA Manuel Utilisateur Exago 1_10 EN Page 17 sur 104 BECM 5 Presentation of the device 5 1 Keyboard description JT ye dg t Fr 693G9 67 6 s G9 s7 s9 J w 3 e 0 0 6 e 06 DEN 2 8 85 97 00 mm ES em Ew um z ID t DEDE R TL I A ST co jm Rl LS LS J 4 ATIENT REPORT hs s A Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 18 sur 104 BECM 5 2 Keyboard function 1 B access B mode operation and B contextual menu When operating in M CFM or PW mode return to B mode B contextual menu includes e Dynamic select Dynamic Range of B image 35 70dB Displayed on screen with Dyn label e Power select transmit Power 30 100 Displayed on screen with Power label e Brightness adjust screen brightness 3 100726 Displayed temporarily on screen with Bright label e Dual access Dual B imaging mode Use Select to switch between left and right images A round dot on display indicates the active image or if in Freeze mode the image that will be unfrozen Use
21. diagnostic ultrasound outweigh the risks if any which may be present References Bioeffects considerations for the safety of Diagnostic Ultrasound Journal of Ultrasound in medicine Vol 7 Number 9 American Institute of Ultrasound in Medicine Bioeffects Committee N Warning Safe use means that the ultrasound scanner must be used according to the ALARA principle meaning that the operator must maintain the transmit power level and the length of the exposure at the lowest possible level As Low As Reasonably Achievable Consequently the operator must use the ultrasound in a safe way in order to ensure the maximum protection of the patient This means that the operator must assume that there might be unidentified risks during the use of ultrasounds and therefore reduce the exposure time of the patient as well as the transmit power This can be done by following the ALARA principle As Low As Reasonably Achievable which associates some simple rules for obtaining a diagnosis while using the least amount of acoustic energy How to perform a safe examination When starting an examination always adjust the transmit power at the lowest possible level Increase the power during examination if necessary in order to obtain a satisfactory image or Doppler signal while keeping the review of MI and or Tl indexes Do not hold the probe in a fixed position longer than necessary As soon as the image has been frozen take the probe away
22. ec E PIT ld IHR tt PMinfPa zs Itaa zs ITT zs cm Associated acoustic parameters pr at max lpi deq at max lpi cm Ipa a at max MI information W cm Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 55 sur 104 BECM 12 Annex IV Tables references and calculations 12 1 List and bibliographic references of obstetrical tables Table Abbreviation type Author Bibliographic reference Chitty L S Altman D G Charts of Fetal Size 3 Abdominal Measurements British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P B CFM Chitty drvd 125 131 Chitty L S Altman D G Charts of Fetal Size 3 Abdominal Measurements British Journal of Obstetrics 8 Gynaecology jan 1994 vol 101 P B CFM Chitty Pltd 125 131 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters B CFM Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology pringer Verlag 1990 B CFM Jeanty SBN 0 387 15348 9 Springer Verlag New York P 179 Norio Shinozuka Haruo Masuda Hideroni Kagawa Yuji Taketani Standard Values o
23. ene 1119 2 8 2 Inspection ae 12H 283 Handing lge 13H 2 8 4 Ultrasound COUPIING Divina dicci n 1312 2 8 5 Surface temperatures eee ee 1412 2 7 END OF PRODUCTILIFE OF THE DEVICE iia 1443 3 INSTALLATION OF THE EQUIPMENT sss ss esse vs voes voes vove eooo eooo 1514 4 CIS ICcE A4p oque 1615 4 1 CONNECTION AND DISCONNECTION OF PROBES eee eere tote ttt cercas teet iate pnto teo Ea Da sene tenero n 1615 4 Re EXAGO TROLLEY n dida 1615 4 3 STARTING OF THE DEVICE Matias ii tit 1615 DA BATTERY OPERATION nn ici 1615 5 PRESENTATION OF THE DEVICE ciccioconoci oincinnococoni ncacaniasanonicanionianacancacidncacaciananccicaniaciocacancadada asa 1816 5 l KEYBOARD DESCRIPTION cata tetitas 1816 5 2 KEYBOARD FUNCTION comisaria etis taie en dun 1917 bo SCREEN ICONS instal tala dial 2825 6 CONNECTION OF PERIPHERALS cscscsssscscssssccessesssccssssscecsscsececssssscecsassccacsassesacsasscsecsassesess 3026 7 CLEANING AND DISINFECTION INSTRUCTIONS ve ss sss seves vove esee ener vove ve veve veeo eo e voeson 3127 7 1 CLEANING AND DISINFECTION OF THE DEVICE eee ee rennen eren Ea err trennen nnns 3127 7 2 CLEANING AND DISINFECTION OF PROBES see 3127 7 2 1 Exteral PODES a i scene aun eun IRE nin 3127 F262 Endo cavity PODES deuda emen ted bdo e quem b revu ed cades 3228 7 3 SUBMERGINGIIMITS tasa 3329 8 LABELING OF THE DEVICE 5 nn in in rites dns oa dE Sand aan ei aS Ro cacdanes 36
24. factory settings Exit exit from the Settings menu 24 Protocol open and display a measurement Protocol The Protocol menu can be used during an examination or independently of an examination Protocols are either factory protocol or user protocol if any see item 23 Selection of protocol is made by clicking on Patient and selecting the application and protocol for the examination in the Exam box In case of use during an examination with a patient file user should first through the Patient menu create and or select a patient select an application select a Factory or User protocol and then start an examination see item 26 Protocol will display on the left side of image the list of measurements to be performed in the protocol When frozen use the contextual key Page or the cursors see item 32 to scroll the protocol list up and down the current measurement result fhe author reference of the current table if any in Application Obstetrics the reference gestational age weeks days if any the estimated gestational age weeks days the date of LMP and the estimated date of birth edd Use of Protocol measurements Freeze the image Select measurement to be performed in the protocol list using the touchpad click on Select or on the Touchpad to initiate first calliper on the image After adjusting position of the first calliper click on touchpad to validate this and to activate the second calliper After adjust
25. kV for input output lines environment Mai lity should be that of Surge 1 kV differential mode 1 kV differential mode a p RE NUMEN i Sie IEC 61000 4 5 2 kV common mode 2 kV common mode ye p environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 UT gt 95 dip de UT for 0 5 cycle 40 UT 60 76 dip de UT for 5 cycles 70 UT 30 76 dip de UT for 25 cycles 5 76 UT 295 76 dip de UT for 5s 5 76 UT 295 76 dip de UT for 0 5 cycle 40 UT 60 dip de UT for 5 cycles 70 76 UT 30 76 dip de UT for 25 cycles 5 76 UT 295 76 dip de UT for 5s Mains power quality should be that of a typical commercial or hospital environment If the user of the Exago equipment requires continued operation during power mains interruptions it is recommended for the Exago equipment to be powered from an uninterruptible power supply Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment possible confusion NOTE 1 UT is the a c mains voltage prior to application of the test level NOTE 2 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity of the Exago equipment NO
26. the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveys should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 2 NOTE 1 t 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity of the Exago equipment a Field strengths from fixed transmitters such as base station for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Exago equipment is used exceeds the applicable RF compliance level above the Exago equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Exago equipment b Over the frequency range 150 kHz to 80
27. to the User Protocol menu to create user defined protocols The contextual menu includes e Create add a new line in the User Protocols list Start by selecting the Application with the Touchpad in the list to the left in which the user protocol should be created User can Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 25 sur 104 BECM select which measurements from the Protocol Items list will be included in the user protocol by clicking on the corresponding box with the Touchpad For measurements having multiple authors user can select the author from the Authors list Protocol name can be modified by typing the new name in the text field located in the lower left part of the menu Press Save when selection is finished e Delete delete the selected User Protocol from the User Protocols list e Save save the created User Protocol e Tables in Obstetrics application display the current protocol table in data or graphical mode Data Graph control Next and Previous controls are used to review equivalent table with different authors if any e Back exit the User Protocol menu and return to the Settings menu To activate a user protocol click on Patient and select the application and protocol for the examination in the Exam box to the right The application and protocol selection can be done with or without opening a patient file see item 246 Reset reset all system settings to default
28. utero analysis of fetal growth A sonographic weight standard Radiology 181 129 133 1991 e HC according to BPD and OFD HC BPD OFD 2 3 1416 Conception Due Date and GA by LMP Conception LMP cycle 28 luteal 14 Due Date Conception 266 days GA by LMP 14 266 Due Date lt today gt formulas in days N Cephalic Index CI CI BPD OFD 100 FL HC ratio FL HC FL AC ratio FL AC HC AC ratio HC AC FL BPD ratio FL BPD Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 93 sur 104 BECM 13 Maintenance of the device Repairing of the device None of the parts of the device can be repaired by any person who has not been authorized by the manufacturer Only a technician who has been trained and qualified by ECM can intervene for reparation of the device In case of breakdown or fault in the functioning of the device contact your distributor You will find the address of your distributor on the first page of this manual Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 94 sur 104 BECM 14 Factory protocols for each application APPLICATION GENERAL Mode B Measure tool Measurement Result CFM Distance Distance Distance Ellipse Ellipse Circumference Surface Trace Surface Angle Angle Stenosis Distance ID Rat
29. 0 9 0 V9 022 E EN 12 9 23 5 20 0 33 9 143 ER ZE 745 DE 247 2044 214 2233 2325 2413 251 2575 2683 27 2857 235 301 6 3054 317 5245 3317 vo a NI a AJN Sal Kal Lal O GI 0 lol Gol a N Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 62 sur 104 BECM AC Hadlock FG SD mm 50 mm SD mm 32 46 59 73 N R w 4 0 5 0 6 0 7 0 8 0 9 0 N w Rh Gs Co ES denk N N N N E N w N 20 0 AC Tokyo FG ET mm 160 1 O Os ES a o N LA N oo da wo N O ka o A N o N N N N e a N es N N N a N E e N O1 wm N A N NINNIN N fJ NISJA w ARIAT NIN N NINININININ OPO ON Ala ojtojo oljojo o NINININ SOTO o OU RES RE RS el so a Wi e oo wm w N e Az Wo WIN apo wj wj ojo wj ajA 0 50 mm 3 16 0 o a oly o el N wje N Ln l ER oIN lL a o oo N N N nm Le E N o a 202 223 233 244 254 264 273 283 292 301 27 35 43 50 57 64 70 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 63 sur 104 BECM APAD Merz FG ee ae BEI Et AXT Tokyo FG Aw sew oe 95 em ps po gt op me o o pp ws AJA Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 64 sur
30. 104 BECM BPD Tokyo FG 5 mm 50 mm 95 mm 105 137 2 0 17 3 0 20 3 23 6 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 65 sur 104 BECM BPD CFEF FG 121 158 TE SH 24 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 66 sur 104 BECM BPD Chitty O O FG e xx ep p O p Re E EX m 192 350 223 E 263 EN 30 1 E399 RA YAA Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 67 sur 104 BECM BPD Hadlock FG age E EC O 7 LE En 132 270 219 EN 254 En 23 AR RA Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 68 sur 104 BECM BPD Osaka Identical ag RT 7 3m TO A Ep 20 167 370 202 250 234 8 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 69 sur 104 BECM BPD Hansmann FG Aw ae A CT CA E 2 0 16 3 0 20 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 70 sur 104 BECM Clavicle Yarkoni FG awe Lat PE S i99 E E CRL Hadlock FG FISD mm Dm 4 LL Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 71 sur 104 BECM CRL Hansmann FG LRT TO A Jo ue EX 8 0 950 123 00 192 CRL Osaka Identical Ae m OR FAA CRL Rempen FG CRL Robinson FG E Ee o AM AR E H a DEER EEN Version
31. 32 9 ANNEX 1 MEASURE ACCURACY eere eee eere ee seene eenn eneon eneon enoe 3733 10 ANNEX Il ELECTROMAGNETICAL COMPATIBILITY eere eere eren ener enero enero tnn 3834 11 ANNEX III ACOUSTIC POWER rores iani root oath reo seene 4238 12 ANNEX IV TABLES REFERENCES AND CALCULATIONS eene ss sees 5652 12 1 LIST AND BIBLIOGRAPHIC REFERENCES OF OBSTETRICAL TABLES 5652 12 2 DETAILED OBSTETRICAL TABLES ee 6056 12 3 FORMULAS EE tec Stara en Ne Sen tates us 9389 13 MAINTENANCE OF THE DEVICE cccsscsscssssscssssscssccssescssscsccssssscsssencssccnseseseacsccsssencsesensescsesesees 9490 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 2 sur 104 BECM 14 FACTORY PROTOCOLS FOR EACH APPLICATION eese erret tatnen reen 9591 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 3 sur 104 BECM 1 Introduction This manual includes all necessary information for installing and using the Exago ultrasound equipment ECM ref 90 1119 used alone or with the Exago trolley ECM ref 90 1541 Exago is an ultrasound device for diagnostic imaging Entirely digital using FPGA technology Exago provides imaging in B M and CFM modes as well as Doppler spectrums Exago is designed for the following applications Abdominal Anesthesia General Gynecology Obstetrics Small parts Urology Vascular
32. B Force store clip Improves storing of clips on some USB flash sticks old or not correctly formatted Network selection to activate DHCP or not by default DHCP is activated In case DHCP is activated the IP address shown in the screen is the one provided by the network If DHCP Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 24 sur 104 BECM is not activated user should enter a valid IP address enter the standard subnet mask as 255 255 255 0 and press Apply Dicom folder e Store Menu Host Storage server IP address Provided by the network administrator Port Storage server Port default value is 104 Provided by the network administrator AE Storage server Application Entity name Provided by the network administrator Local AE Exago system Application Entity name Allocated by the network administrator Interpretation image format Pallete by default If not accepted by the server select RGB Red Green Blue or Monochrome no color Compression image compression type None by default RLE compressed Immediate Storage If the box is ticked the transfer to the DICOM server is immediate when pressing store When not ticked the Dicom images can be saved in a Patient Report in Dicom format on the internal memory or on an external USB device and transferred later to the Dicom server by the key Dicom Store in the contextual report menu It is recommended to enter a Patient ID if Dicom sto
33. BECM EXAGO User Manual Version 1 10 C Eoss CE certificate for the ultrasound scanner Exago obtained in 2010 Exago reference 90 1119 Indice A User Manual reference 70 3326 Warning This manual must be read before using the equipment Manufacturer s address Distributor s address de Beiter eee eas 126 bd de la R publique eese F 16000 Angoul me eseeeee A T l 433545920357 cc Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 1 sur 104 BECM SUMMARY 1 INTRODUG TION sissiscsssiciscsassssnssciisseccsdiscsssnseccetesesuocseosucdesesdsvossesuapsetessevecsasdsedadesdseseceovassusasssceucescssvsboutusivessecees 4 2 SAFETY INSTRUCTIONS ee 5 2 1 SAFETY INSTRUCTIONS FOR ULTRASOUND EQUIPMENT sise 5 Qed USEF E aiii 5 2 12 ACOUSIIC PO ME x sen X 5 2 1 3 Interpretation of MI and TI parameters sisi 5 2 1 4 Accuracy of MI and TI parameters display 6 ENS RETOS dE 6 2 3 ENVIRONMENTAL CONDITIONS OF USE iia ia 7 ZA ELECTRICAS A ec 7 2 5 PATIENT ENVIRONMENT ete tetieeiestestesece ts tenaient etienne dou deett pies eebe 109 2 6 ELECTROMAGNETIC COMPATIBILITY cceccsssseeecseseeecsessesecsesscsecsesscsecsevscsecsesacsecsesscsecsesassecsesscsecsesaseessesaseess 109 2 7 PROBE AND EQUIPMENT COMPATIBILITY NEEN 1110 2 0 PROBE INFORMATION a P Ret tete bee vee 1119 2 8 1 Probe types and corresponding applications
34. D MA Manuel utilisateur Exago 1_10 EN Page 89 sur 104 BECM alias A PI Schaffer FG Left Uterine RI Schaffer FG owa 05 7 T Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 90 sur 104 BECM Left Uterine PI Schaffer Age 55 OH HC 044 04 54 038 owa 04 o H wa 00 0 6 H Right Uterine RI Schaffer FG BEER 988 64 L OS Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 91 sur 104 BECM Right Uterine RI Schaffer FG Age 5 OH 955 034 033 94 HT 032 03 Right Uterine PI Schaffer FG Age 55 OH Cat 04 94 L9 TT MITIN 00 EE 9 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 92 sur 104 BECM 12 3 Formulas N Estimated Fetal Weight EFW author Hadlock Hadlock AC FL Log10 EFW 1 304 0 05281 AC 0 1938 FI 0 004 FL Hadlock BPD AC FL LoglO EFW 1 335 0 0034 AC FL 0 0316 BPD 0 0457 AC 0 1623 FL Hadlock HC AC FL LoglO EFW 1 326 0 00326 AC FL 0 0107 HC 0 0438 AC 0 158 FL Hadlock BPD HC AC FL LogIO EFW 1 3596 0 00386 AC FL 0 0064 HC 0 0006 1 BPD AC 0 0424 AC 0 174 FL EFW in grammes g HC FL AC et BPD in centimetres cm Hadlock FP Harris RB Matinex Poyer J ln
35. Dimaan X 0 0 o od a T o parameters EE Other Ipa a at max MI information W cm Probe model C360R Mode M E MD E index label Aaprt lt 1 cm Aaprt gt 1 cm L E Us ST mem O Associated acoustic parameters mamabi 28 l deqatmaxii em Ipa a at max MI information W cm Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 47 sur 104 BECM Probe model L738P Mode B mode 2D po mom Non scan pss DEER EE ECTS Maximum Index Values Pap minpParzs taz fo AA SSS sm IE q q o ql E zp em dO q q q 5 Io ca zoem 0 o o o ih zatmaxpiacm 3 1 ooo Ir o E Associated fawMHz________ 7 J 798 141 0 12 e acoustic DimAapt X Jo og 141 1 a Ec parameters pratmax pi 68 III deg at max Ben 0 o o oo oo TT Ipa a at max MI information W cm 371 D A Probe model L 738P Mode CFM Index label ET Aaprt lt 1 cm Aaprt 1 cm E TIC 018 Maximum Index Value Dies pama ro o LL oo CP o 4 74 1 1 a MinPazs taazs dl A Iz om gj LOL LIC zp em 1d dl LT 1 y zoom zatmaxip acm 3 deq zb c po HM tdos Associated fawf MES 797806 1 0 ___ _ y acoustic DmAapt X J 09 J CAR IE parameters deq at max Ipi cm gt Ipa a at max MI information em _ _ Version 1 du 03 05 2013 R f CD MA Manuel utilisateu
36. Left Uterine Artery Heart Rate Right Uterine Artery Heart Rate Left Ovary Artery Heart Rate Right Ovary Artery Heart Rate Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 102 sur 104 BECM APPLICATION UROLOGY Mode B CFM Organ Measurement Result Bladder Width WxHxD x Pi 6 Height Volume Depth Prostate Width W xH xD x 0 52 Height Volume Depth Testes Width WxHxD x Pi 6 Height Volume Depth Left kidney Width Height Right kidney Width Height APPLICATION UROLOGY Mode PW Organ Measure tool Left Renal Artery Doppler Auto Rate Right Renal Artery Doppler Auto Rate Doppler Auto RI Pl Speed Systole Speed Diastole S D APPLICATION UROLOGY Mode M Organ Measurement Left Renal Artery Heart Rate Right Renal Artery Heart Rate Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 103 sur 104 BECM APPLICATION SMALL PARTS Mode B CFM Organ Measurement Result Testes Width WxHxDxPi Height Volume Depth Thyroid Width WxHxDx0 479 Height Volume Depth Breast Width WxHxDxPi Height Volume Depth Prostate Width WxHxDxPi Height Volume Depth Hipjoint left Angles Alpha Beta Hipjoint right Angles Alpha Beta APPLICA
37. ON ABDOMINAL Mode PW Organ Measure tool Left Renal Artery Doppler Auto Rate Right Renal Artery Doppler Auto Rate Hepatic Artery Doppler Auto Rate Portal Vein Doppler Auto Rate Aorta Doppler Auto Rate Doppler Auto RI PI Speed Systole Speed Diastole S D Rate Heart Rate APPLICATION ABDOMINAL Mode M Organ Measurement Left Renal Artery Heart Rate Right Renal Artery Heart Rate Hepatic Artery Heart Rate Portal Vein Heart Rate Aorta Heart Rate Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 101 sur 104 BECM APPLICATION GYNECOLOGY Mode B CFM Organ Measurement Left ovary Width Height Depth Volume Right Ovary Width Height Depth Volume Uterus Width Height Depth Volume Ovarian follicle Distance 1 Distance 2 Distance 3 Endometrium thickness Thickness APPLICATION GYNECOLOGY Mode PW Organ Measure tool Left Uterine Artery Doppler Auto Rate Right Uterine Artery Doppler Auto Rate Left Ovary Artery Doppler Auto Rate Right Ovary Artery Doppler Auto Rate Doppler Auto RI Pl Speed Systole Speed Diastole S D Rate Heart Rate APPLICATION GYNECOLOGY Mode M Organ Measurement
38. Subclavian Artery Left Subclavian Artery Distance Surface 76 Stenosis Distance Stenosis Surface Right Subclavian Artery Right Subclavian Artery Distance Surface Stenosis Distance Stenosis Surface Innominate Artery Innominate Artery Distance Surface 76 Stenosis Distance 76 Stenosis Surface Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 98 sur 104 BECM APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Left Com Carotid Artery Left Common Carotid Doppler Auto Artery Rate Right Com Carotid Right Common Carotid Doppler Auto Artery Artery Rate Left Ext Carotid Artery Left External Carotid Artery Doppler Auto Rate Right Ext Carotid Artery Right External Carotid Artery Doppler Auto Rate Left Int Carotid Artery Left Internal Carotid Artery Doppler Auto Rate Right Int Carotid Artery Right Internal Carotid Artery Doppler Auto Rate Left Vertebral Artery Left Vertebral Artery Doppler Auto Rate Right Vertebral Artery Right Vertebral Artery Doppler Auto Rate Left Subclavian Artery Left Subclavian Artery Doppler Auto Rate Right Subclavian Artery Right Subclavian Artery Doppler Auto Rate Innominate Artery Innominate Artery Doppl
39. T zem oo ooo LLL LLL L Ip em PE EE A zea ooo pp zatmaxipiaem 3 0 _ den cm T Associated fawMHz________ 618 1 516 _______ _ 616 ao acoustic DimAaptX_____ _________ ________ _ oe A Io X parameters O IS OS dus H T E LL O gt lprHz seo pratmax li _2t8__ ___ ______ deg at max bon 0 0 0 Other Ipa a at max MI information e Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 51 sur 104 BECM Probe model E610R Mode B Do TS B Non scan Maximum Index Value P mw Min Pa zs lta a zs zs cm deq zb cm Associated acoustic DimAapt X Il o2 1 0 1 0 ei parameters Y__________ _______ __0ss__ ____ y dus CE pp perez P o E degatmaxipi em Other Ipa a at max MI information W cm Probe model E610R Mode CFM Do TIS TB ll Nonscan ES dO Maximum Index Value 15 f 026 TE CC Pe ZS Fat EE pe Associated LS MIEL 629 616 629 III o acoustic Din Aaprt X OE H 9 38 Yoo parameters prat max D esa deg at max ler om gt gt gt Ipa a at max MI information wer Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 52 sur 104 BECM Probe model E610R Mode PW TS TB j Nonscan O Index label Mr Aaprt l
40. TE 3 The essential performance of the equipment considered for the compliance to the standard is defined as the correct visualization on the screen of an area of interest centered at 5 cm s depth with the C360 probe using default settings on a ATS model 53 phantom The ultrasound image includes both hypoechogenic and hyperechogenic targets that should stay visible without any Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 39 sur 104 BECM TABLE 4 Guidance and manufacturer s declaration electromagnetic immunity The Exago equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Exago equipment should assure that it used in such an environment Compliance Immunity test IEC 60601 test level level Electromagnetic environnement guidance Portable and mobile RF communications equipment should be used no closer to any part of the Exago equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP 150 kHz to 80 MHz Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 1 2V P 80 MHz to 800 MHz Radiated RF 3V m 3V m IEC 61000 4 3 80 MHz to 2 5 GHz d 2 34 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is
41. TION SMALL PARTS Mode PW Organ Measure tool Breast Doppler Auto Rate Prostate Doppler Auto Rate Testes Doppler Auto Rate Thyroid Doppler Auto Rate Doppler Auto RI PI Speed Systole Speed Diastole S D APPLICATION SMALL PARTS Mode M Organ Measurement Breast Heart Rate Prostate Heart Rate Testes Heart Rate Thyroid Heart Rate Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 104 sur 104
42. Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 22 sur 104 BECM o Possibility of making measurements on a paused image in post processing and storing of this Press Freeze to exit the cineloop mode e Rename rename the selected image or clip e Delete delete the selected image or clip e Exit exit the Review menu 14 Freeze freeze and unfreeze system In Freeze mode 3 contextual menus are available Cineloop Measure and Protocol See details of Measure in item 6 of Cineloop in item 8 and of Protocol in item 24 descriptions 15 Depth and adjust image Depth Image Depth is displayed on screen bottom of depth scale 16 Gain and adjust Gain of current imaging mode B PW or CFM Gain is displayed on screen label Gain 17 Frequency access Frequency selection menu Three available transmit frequencies are selectable in each mode using the contextual keys The operating Frequency is displayed on screen label Freq Same key is used to exit the Frequency selection menu If no contextual keys are used for 15 seconds the system automatically exits the Frequency menu If the option Tools Circular selection Focus amp Frequency in the Setting menu is active the Frequency button automatically brings the frequency from one step to the next in a circular way 18 Focus access transmit Focus selection menu Five available transmit Focus are selectable in B mode using the contextual keys
43. ______ _ parameters YAA A ds AR AA lpgrHz AA L A o o o degatmax pi cm Other Ipa a at max MI information TEE Probe model E610A Mode CFM oo TS TB ll Nonscan poe RA CA Maximum Index Value E o 1425 0148 pra MPa O O ITU SR H Min Pa zs ttaa zs dl dl 5 D DL zm 1 dl LL zp om 1d dl SE 1 zoom O O O E Z amas pi acem 3 deqzo cm A Associated fawf MHz 629 616629 J To acoustic DimAapt X o oe 9 parameters Y os ei dus lf 027 12 TS logmz dl ty mem o o o degatmax pi cm Other Ipa a at max MI information O Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 50 sur 104 BECM Probe model E610A Mode PW po mo TB seen E sean e 214 w Maximum Index Value 117 17 ELA A AA Pow 05 Min Pa s Itaa z s _ ___ __ _______ AAA amada AJA Den mm Associated faw MHz oe 616 acoustic DimAapt XA 08 parameters E Im pjs RA E 1 Por Hz EE RER RRE 4 p deg atmaxipi om A Other Ipa a at max MI information Rem 4 Probe model E610A Mode M Non scan Index label DE Aaprt lt 1cm Aaprt gt 1 cm TIC Maximum Index value ___ozs__ ___ __07 tg pampa 16 1 0 1 CE 0 2692 0 262 a Min Pa s ttaa P
44. ad can lead to electrical shock Never use a probe that is damaged that has been dropped or has been suffering a severe collision until it has been inspected by an ECM customer service engineer Warning Do not bend or twist the transducer cable If the transducer housing becomes cracked or broken or if there are cuts or openings in the cable the electrical safety features of the transducer might be compromised Warning Do not immerse the transducer connector in any liquid Immersing it can destroy its electrical safety features 2 8 4 Ultrasound coupling gel Some ultrasound coupling gels and lotions can damage the probes Agents containing the following chemicals are known to damage transducers Acetone Methanol Denatured ethyl alcohol Mineral oil lodine Any lotion or gel that contains perfume N Warning Check the gel contents with your gel supplier N Warning To avoid any problems regarding the use of ultrasound coupling gel please respect the following rules e Always check the expiry date on the gel bottle prior to use on a patient Always throw expired bottles away e Choose 250ml conditioning rather than 5 liters Never use a 5 liters bottle to fill smaller bottles each day Throw away all started bottles at the end of the day e Before the probe disinfection procedure between each examination wipe off all gel residues on probe head housing and cable Version 1 du 03 05 2013 R f CD MA Manuel utili
45. age or clip e DICOM store Transfer of previously stored Dicom files to the Dicom server Only possible when the images are stored in a patient report Select the report and press Dicom Store If no ID has been allocated before the device will ask you to do it See item23 about Dicom folder Immediate Storage Exit by pressing Report If an examination is under progress Report will directly access viewing the current report under progress o Page 1 move to next report page o View display stored image from the current report under progress Previous display the previous image in the image list from the current report Next display the next image in the image list from the current report Rename rename the selected image Delete delete the selected image Bock return to the upper level menu o Directories return to Directories selection menu USB device if connected or internal memory See above o Press Report to exit and return to current examination 26 Patient access to the Patient menu allowing to review and store Patient data examination information including Application and Protocol selection e Patient List access to stored Patient data from USB device if connected or internal system memory Click with touchpad to select an existing patient Clicking on Last name or ID will sort out the patients accordingly o Search Easy search of existing patients by name or ID o Delete delete selected patient wi
46. anios Cidex OPA It is strongly recommended to use one of these solutions in order to avoid any deterioration during the cleaning and disinfection procedure A WARNING The use of any other disinfecting solution than the ones indicated above is dangerous as it may damage the probe components Check the list of specified agents carefully In order to ensure proper cleaning and disinfection please follow the following procedure 1 After every patient examination wipe the ultrasound transmission gel off the probe 2 Unplug the probe connector from the system 3 Wipe the probe and cable with a clean soft cloth that has been damped in a solution of mild soap and water 4 Follow carefuly the low level disinfection instructions indicated by the disinfectant manufacturer 5 Remove any cleaning solution residue with a soft clean cloth dampedi in sterile water 6 Air dry or dry with a soft clean and dry cloth 7 2 2 Endo cavity probes Endo cavity probes have a medium infection risk This risk level corresponds to the use of so called semi critical medical devices which means devices which are in contact with mucus membranes or superficially injured skin The needed treatment for this type of medical device is a medium level disinfection Low level disinfection procedure N WARNING The endo cavity probe supplied with the Exago device must be used with a sterile cover over the probe casing which will be in contact with the mucus mem
47. art Rate Left Uterine Heart Rate Right Uterine Heart Rate MCA Middle Cerebral Artery Heart Rate UA Umbilical Artery Heart Rate Version 1 du O 3 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 97 sur 104 BECM APPLICATION VASCULAR Mode B Abbreviation Organ Measure tool CFM Left Com Carotid Artery Left Common Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Right Com Carotid Artery Right Common Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Left Ext Carotid Artery Left External Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Right Ext Carotid Artery Right External Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Left Int Carotid Artery Left Internal Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Right Int Carotid Artery Right Internal Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Left Vertebral Artery Left Vertebral Artery Distance Surface Stenosis Distance Stenosis Surface Right Vertebral Artery Right Vertebral Artery Distance Surface Stenosis Distance Stenosis Surface Left
48. branes This cover is for single use only The following disinfection solutions have been tested and their compatibility with the components of the probes has been proved Alkazyme Klenzyme Cidezyme Nu Cidex Anioxyde Gigasept FF Steranios Cidex OPA It is strongly recommended to use one of these solutions in order to avoid any deterioration during the cleaning and disinfection procedure N WARNING The use of any other disinfecting solution than the ones indicated above is dangerous as it may damage the probe components Check the list of specified agents carefully In order to ensure proper cleaning and disinfection for endo cavity probes please follow the following procedure After every patient examination remove the single use sterile cover and throw it away Wipe the ultrasound transmission gel off the probe Unplug the probe connector from the system Wipe the probe and cable with a soft clean cloth that has been damped in a solution of mild soap and water EOT Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 32 sur 104 BECM 5 Follow carefully the medium level disinfection instructions indicated by the disinfectant manufacturer Remove any cleaning solution residue with a soft clean cloth damped in sterile water Air dry or dry with a soft clean and dry cloth 6 7 A WARNING The specified disinfectants have been tested for compatibility with the probe
49. c parameter for fetal evaluation Clavicle Length Clavicle B CFM Yarkoni J Ultrasound Med 4 467 470 1985 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 56 sur 104 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 440 441 FG FG FG FG FG FG FG FG FG FG FG FG FG FG FG BECM Hadlock FP Shash YP Kanon DJ Lindsey JV Fetal Crown rump length Reevaluation of relation to menstrual age 5 18 weeks with high resolution real time US Crown rump Length CRL FG B CFM Hadlock Radiology 1992 182 501 505 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 438 Mineo Aoki Motohiro Yamada Evaluation of fetal growth B CFM Osaka Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Rempen A Biometris in der fruehgravitaet I trimenon B CFM Rempen der Frauernarzt 32 1991 425 430 H P Robinson Honory Senior Registrar A critical evaluation of sonar crown rump length measurements British Journal of Obstetrics and Gyneacology September B CFM Robinson 1975 82 702 710 Takashi Okai Department of Obstetrics and Gynecology Faculty of Medicine University of Tokyo Studies on Fetal Growth and Functional Developments Official Journal of t
50. ce PW mode Press Select to return to Active PW mode When the PW is activated in B CFM mode pressing the update button returns to the B CFM mode with the PW gate displayed 4 M display M line set M line position with Touchpad press Select to start M mode display Press Update to return to M line adjustment Press Select again to start M mode display 5 lt in Freeze mode move to previous Cineloop image Current image index is displayed on screen 6 Measure freeze the system if operating live and access Measure menu Accessing the Measure menu will automatically initiate a first Distance measurement Measure contextual menu includes Distance start a new Distance measurement with display of first calliper Adjust first calliper position with Touchpad and click on Touchpad for first calliper position validation and display of next calliper Adjust second calliper Press Select to go back to first calliper adjustment or click on Touchpad to terminate the Distance measurement Distance values are displayed on screen with identification and color code Four distances can be acquired on the same image If the option Tools Distances in sequence in the Setting menu is active once a distance measurement is completed the system automatically displays the first calliper of the next distance measurement see item 23 Ellipse start a new Ellipse measurement with display of first calliper Adjust first calliper position with Touchpad and cli
51. ce of the needle gt Warning On probes C360V and C360A check that the biopsy needle is situated at the same side as the orientation marker of the probe gt Warning On probe E610A check and confirm by clicking OK that the system will display a biopsy guideline dedicated to medical application e Exa Cross activate the Cross Beam function The angle can be adjusted with the arrow cursors see item 32 Exa Cross can be used in B and Dual B Active only on the linear probe Press Exa Cross again to exit e Large image activate the function Large Image where the images uses a maximum of the screen Large Image can be used in B and Dual B Active only on the linear probe Press Large Image to exit e Smooth select smoothening level among 0 no smoothening 1 and 2 Displayed temporarily on screen with Smooth label Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 19 sur 104 BECM Next Previous used to explore next and previous levels of the contextual menu The selection is circular and gets from the last page to the first again A gauge indicates which level of the menu is currently used B gain is adjusted with the Gain keys see item 16 2 CFM access CFM display and menu The CFM box Position can be adjusted using the touchpad Press Update to go to Pre trace CFM mode for adjustment of the CFM box size position and Steering angle Pre trace CFM contextual menu includes Positio
52. ck on Touchpad for first calliper position validation and display of next callipers Adjust second calliper Press Select to validate second calliper and go to third calliper to adjust this Press Select to go back to first calliper adjustment or Click on Touchpad to terminate the Ellipse measurement Ellipse values are displayed on screen with identification and color code Two ellipses can be acquired on the same image Trace start a new Trace measurement with display of first calliper Adjust first calliper position with Touchpad and click on Touchpad for first calliper position Draw the Trace contour on image using the Touchpad and click on Touchpad to terminate the Trace measurement If the drawn contour is not closed a straight line will be used to close the contour and allow surface and perimeter calculation Trace values are displayed on screen with identification and color code One single Trace can be acquired on the same image Select select one distance ellipse or trace among all items displayed on screen Selected item and related measurements are highlighted Delete delete the selected measurement on screen Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 21 sur 104 BECM Press Measure to exit the measurement menu and Freeze to unfreeze and return to live imaging 7 Update Mt in operating M Mode freeze M display and return to live operation of B mode for M line adjustment by Touchpad After
53. ctive imaging Tools Centimetre grid on B When enabled a centimetre grid is active on B and Dual B images Tools PW Pretrace CFM this selection authorizes the display of PW pre trace mode displaying the PW Gate line on an active CFM image Active by default Tools Circular selection Focus amp Frequency When enabled the Frequency and Focus buttons automatically bring the frequency and focus from one step to the next in a circular way Active by default See item 17 and 18 Tools Logo at the bottom When enabled the EXAGO Freeze logo is displayed in the lower part of the screen Annotation folder Annotation key F1 to F10 selection of user defined annotations as a free text These annotations can be used in the Text function and can be selected using the F numeric keys as shortcuts See Text function item 27 Restore last annotation Repeat the latest free text not from the annotation list entered with the Text function item 27 automatically when pressing Text System folder Date format selection of date format DD MM YYYY YYYY MM DD MM DD YYYY Time format selection of time format 24 H or 12 H System date selection of current date System time selection of current time Auto Freeze selection of Auto Freeze time period after which the system will automatically freeze if no key has been used Can be selected as 5 min 15 min 30 min About displays system information as software revision level US
54. ed indication is obtained by a computation based on the angle correction information which is manually entered by the user As an indication only the speed information would be accurate at 5 of the full scale speed in the hypothetical case where there would be absolutely no uncertainty on the angle correction estimation Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 37 sur 104 BECM 10 Annex II Electromagnetical compatibility TABLE 1 Guidance and manufacturer s declaration electromagnetic emissions The Exago equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Exago equipment should assure that it used in such an environment Emission tests Compliance Electromagnetic environment guidance The Exago equipment uses RF energy only for its internal function RF Emissions E Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 SE The Exago equipment is suitable for use in all establishments other than domestic and can be used in domestic establishments and those directly Class A connected to the public low voltage power supply network under the Harmonic emissions CHI 61000 3 2 condition of the following warning Warning This equipment system is intended to be used by health Voltage fluctuations professionals T
55. el Utilisateur Exago 1_10 EN Page 35 sur 104 BECM 8 Labeling of the device Reference label for Exago with indication of serial number BECM 3 Z EXAGO ER Use exclusively power adapter Protek PMP120 13 2 B2 ECM 126 bd de la R publique C F 16000 Angoul me 0459 MADE IN FRANCE Battery label a E E M Lithium lon Battery E Rating 14 4 V 10400 mAh Ads Risk of excessive temperature fire or explosion ECM if replaced by incorrect type 126 bd de la R publique am C 0459 F 16000 Angoul me MADE IN FRANCE Protection packaging label with temperature and humidity precautions for transport and stocking Il y DO NOT STACK FRAGILE 60 C Humidity 10 to 85 Storage Temperature 10 C to 60 C BECM E Noveko Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 36 sur 104 BECM 9 Annex 1 Measure accuracy Measurement Range Accuracy Distance and ellipse perimeter Up to 30 cm t 5 ou Imm below 2 cm See note 2 Up to 100 cm 5 ou Imm below 2 cm t 1096 ou 40 Y n below 4 rf 2 Surface Up to 1000 cm 2 t 16 ou lt 3c below 8 E Up to 30 sec lt 5 of full scale Cardiac beat frequency O lt value lt 600 BPM Note 1 The PW Pulsed Wave Doppler speed information provided by the equipment is only indicative The equipment is performing an accurate measurement of the Doppler frequency shift but spe
56. er Auto Rate Doppler Auto RI PI Speed Systole Speed Diastole S D APPLICATION VASCULAR Mode M Abbreviation Organ Measurement Left Com Carotid Artery Left Common Carotid Heart Rate Artery Right Com Carotid Right Common Carotid Heart Rate Artery Artery Left Ext Carotid Artery Left External Carotid Artery Heart Rate Right Ext Carotid Artery Right External Carotid Artery Heart Rate Left Int Carotid Artery Left Internal Carotid Artery Heart Rate Right Int Carotid Artery Right Internal Carotid Artery Heart Rate Left Vertebral Artery Left Vertebral Artery Heart Rate Right Vertebral Artery Right Vertebral Artery Heart Rate Left Subclavian Artery Left Subclavian Artery Heart Rate Right Subclavian Artery Right Subclavian Artery Heart Rate Innominate Artery Innominate Artery Heart Rate Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 99 sur 104 BECM APPLICATION ABDOMINAL Mode B CFM Organ Measurement Spleen Dist A Dist B Left Kidney Width Height Right Kidney Width Height Pancreas Head Body Tail Duct Gall Bladder Width Height Wall T Liver Width Height Prostate Width Height Depth Volume Aorta Diameter Diameter Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 100 sur 104 BECM APPLICATI
57. erte in der Schwangershaft Za Mai Geburish u Perinat P 221 222 Mai ai d O z d d H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOURNAL FUR FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft 1 Geburish u Perinat P 221 222 Umbilical artery RI d Umbilical artery RI R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft 1 Schaffer Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft E M Geburish u Perinat P 221 222 NB The obstetrical tables Chitty drvd are made to be used with a circumference calculated from two measured diameters The Obstetrical tables Chitty Pltd are made to be used with a circumference measured as an ellipse It is tnus recommended in case of using the Chitty tables to choose the Pltd version Precisions on GA dating The values used by the software might present minor differences compared to the values published by the authors because of procedures used for representing the digital data These differences generate minimal margins of error cf below which are added to the margins of error indicated by the authors For all the tables Margin of error GA 1 day Table BPD Hansmann Margin of error GA 2 days Table Tokyo Okai Ma
58. es CFM sensitivity and slightly decreases CFM Frame Rate Displayed temporarily on screen with Packet label Burst select the number of cycles in the transmit burst with Burst index 1 3 Higher Burst index increases CFM sensitivity and slightly decreases CFM spatial resolution Displayed temporarily on screen with Burst label Power select the CFM transmit power 30 100 Displayed temporarily on screen with Power label Persistence select the Persistence index 1 8 Persistence is a Frame averaging on CFM image Displayed temporarily on screen with Persist label Spatial Filter select the SpatialFilter index 1 3 Smoothening of the CFM image Displayed temporarily on screen with SFilter label Invert select inversion of color scale CFM gain is adjusted with the Gain keys see item 16 Press Update to switch from Active CFM mode to Pre trace CFM mode Press Select to return to Active CFM mode 3 PWD access Pre trace PW display and menu Pre trace PW mode allows to adjust the PW gate position and size on the B image or B CFM image and to adjust Steering and Angle parameters before starting PW active mode Pre trace PW contextual menu includes Gate Size select Gate Size by pressing and keys Selected Gate Size is displayed on screen Steering select Steering angle by pressing and keys The PW line is updated on the display By default the Steering angle is equal to previous PW o
59. ex label MA re TIC a Maximum Index Value 129 03 la E q lt A NA Pmww 3 ____ _ __ y Min Pa s ttaa s _____ _____ _ _ Iz om zs cm C2 at max pi acm 8 0 5 tm 939 I I s Associated fawMHz 354 8341354 Jo o o ei acoustic Dim Aen Xx 201 0 J 5 5 ei parameters S EE dus 038 1 0 0 0 1 0 0 0 0 0 0 o E58 e AAA Fra me Lo O O O S deg at max bon IT Other Ipa a at max MI information gg Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 44 sur 104 BECM Probe model C360A Mode PW 1S TB l Index label sen Denier repro Maximum Index Value peel l H zs cm zp YAA ER DEER ER em _ _ s 65 JT zatmaxlpiacm_ __8___ _____ _ dea zo cm E G G Associated RI dn la acoustic DimAaptx parameters Ee EE PE ES w E E E O ES perez o so 0 0 0 p A HE O O O O deg at max Ip em AJA Other Ipa a at max MI information US Probe model C360A Mode M EM P uses A Dam TR II mt me CEA ts MiPazs taazs S 0 0 9521 0 0 0 y AA pa 4 eem lo lo No do Aa d zm pp o 65 65 DJ _____ C2 at max pi acm 8 o 5 Associated fawMHz o 341 __ _______ _____ __3n__ los 9 acoustic DimAaptx J 1 1 dl 23 24 a parameters ESSES dus am 1 TEN IE EE LLL perez so _
60. f Ultrasonographic Fetal Biometry B CFM Tokyo Jpn Med Ultrasonics Vol 23 No 12 1996 P 877 888 Merz E Anteroposterior Abdominal Ultrasound in Gynecology and Obstetrics Diameter B CFM Merz Stuttgart New York Thieme Medical Publishers Inc 1991 P 312 Anteroposterior trunk Standard Diameter by Transverse Values of Ultrasonographic Fetal Biometry Trunk Diameter APTD TTD Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements British Journal of Obstetrics 8 Gynaecology jan 1994 vol 101 P Biparietal Diameter B CFM Chitty o o 35 43 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Norio Shinozuka Haruo Masuda Hidenori Kagawa Yuji Taketani B CFM Tokyo Jpn Med Ultrasonics Vol 23 NO 12 1996 P 877 888 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters B CFM Hadlock Radiology 1984 152 497 502 Mineo Aoki Motohiro Yamada Evaluation of fetal growth B CFM Osaka Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Norio Shinozuka Haruo Masuda Hideroni Kagawa Yuji Taketani Standard Values of Ultrasonographic Fetal Biometry BPD B CFM Tokyo Jpn Med Ultrasonics Vol 23 No 12 1996 P 877 888 Yarkoni S Schmidt W Jeanty P et al Clavicular measurement A new biometri
61. from the patient s skin Do not continue the examination longer than necessary It is important to reduce the time of patient exposure to ultrasounds as much as possible 2 1 3 Interpretation of MI and TI parameters It is the operator s responsibility to foresee the risks linked to the output energy of the device and to act appropriately in order to obtain the necessary diagnostic information with a minimum risk for the patient Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 5 sur 104 BECM In order to do this the operator has two indexes displayed on the screen MI and TI respectively Mechanical Index and Thermal Index enabling him to continuously have an indication of the acoustic transmit power level The relationship between different parameters of acoustic power and biological evaluation criteria is not well known today Two fundamental phenomena have been identified mechanical and thermal through which ultrasounds might have biological effects The MI and Tl indexes have been developed to take these phenomena into account and to give the user immediate information on the potential mechanical or thermal biological effects Please notice that these indexes do not take accrued effects into account The MI index mechanical index is related to the spatial peak of the maximum rarefaction pressure providing an indication according to the cavitation effect There is a strong agreement that biological effect
62. he Japan Society of Obstetrics and Gynecology B CFM Tokyo ACTA OBST GYNEC JPN Vol 38 No 8 pp 1209 1217 1986 Chitty L S Altman D G Charts of Fetal Size 4 Femur Length British Journal of Obstetrics 8 Gynaecology jan 1994 vol 101 P B CFM Chitty 132 135 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters B CFM Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 Mineo Aoki Motohiro Yamada Evaluation of fetal growth Osaka Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Norio Shinozuka Haruo Masuda Hideroni Kagawa Yuji Taketani Standard Values of Ultrasonographic Fetal Biometry Tokyo Jpn Med Ultrasonics Vol 23 No 12 1996 P 877 888 Mineo Aoki Motohiro Yamada Evaluation of fetal growth mam Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Rempen A Biometris in der fruehgravitaet I trimenon m der Frauernarzt 32 1991 425 430 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Ha
63. his equipment system can cause radioelectric Flicker emissions Complies perturbations or it can affect the behaviour of a nearby electronic CEI 61000 3 3 equipment It may be necessary to take attenuation measures like re orienting or relocating the Exago equipment or shielding the location NOTE 1 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity of the Exago equipment Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 38 sur 104 BECM TABLE 2 Guidance and manufacturer s declaration electromagnetic immunity equipment should assure hat it used in such an environment The Exago equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Exago Immunity test IEC 60601 test level Compliance level Electromagnetic environnement guidance Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of transient burst a a typical commercial or hospital IEC 61000 4 4 1 kV for input output lines 1
64. i Schaffer Margin of error has not been pr cised the use of these tables is to be avoided The Gestational Ages obtained by calculations of Fetal Aorta PI Fetal Aorta RI Left Uterine PI Left Uterine RI Right Uterine PI Right Uterine RI MCA PI MCA RI Umbilical Artery PI Umbilical Artery RI are for information only d Umbilical artery Pl LL LL LL LL LL LL LL O v z Umbilical artery PI Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 59 sur 104 BECM 12 2 Detailed obstetrical tables AC Jeanty FG 340 4 0 540 AC CFEF FG Version 1 du 03 05 2013 o o o o s o v o 9 8 Nooo 2 N N 0 o x o i elojlo o x 9 als N Eee SINIS o a OI NOS RY Ww O AJOJN NI o 5075 mm R f CD MA Manuel utilisateur Exago 1 10 EN vo o xle eo sxlv 2lol RPOCPTOP S HPO elo o olalolw r rRlejfo r e Page 60 sur 104 BECM AC Chitty drvd FG 20d 48 3w0d ES 683 79 1 90 3 01 5 DE 99 5 ER 19 5 SR 372 485 EE 168 86 6 957 2047 2135 2223 2305 239 3 247 6 2557 2637 2715 279 286 6 2938 3005 307 8 3145 so 00 1 ml AR co o Seil bi 00 NISO MI do to N NEO ES o Os Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 61 sur 104 BECM AC Chitty Pltd FG 3 mm 50 mm 97 mm 240 477 3 0 58 7 4 0 69 7 5 0 80 6 6 0 91 4 7 0 8
65. ina for the following applications General gynecology obstetrics urology The indicated applications can be examined in B PW or CFM modes or in combined modes A Warning Do not use the probe for any other application than the one specified since the probe type and frequency are related to the clinical application This can lead to bad diagnostic resulting from a non adapted image quality It can also lead to useless irradiation of the patient which is contrary to the ultrasound imaging safety guidelines All probes provided with the Exago device are compliant with the standard ISO 10993 1 concerning biocompatibility of components used for probe manufacturing References for Biopsy needle guides Provider CIVCO www civco com Linear L738P Bracket reference Civco 612 085 to be used with needle guide 610 608 compatible with the needles 8 5FR and gauge 14 to 23 except gauge 19 This bracket reference is a re usable bracket needle guides are disposable Endo cavity E610A Reference bracket and needle guide Civco 610 604 or 610 605 compatible with needles gauge 16 to 18 Endo cavity E6TOR Reference bracket and needle guide Civco 610 987 or 610 988 compatible with needles gauge 16 to 18 Provider PROTEK www protekmedical com Convex C360V and C360A Bracket reference Protek 7138 to be used with needle guide ref 4222 22 Ga ref 4218 18 Ga ref 4216 16 Ga This bracket reference is a re usable bracket needle guides
66. ing position of the second calliper click on touchpad to validate the measurement or press Select to return to the previous calliper for readjustment before validating the measurement by clicking on the touchpad Measurement result and estimated Gestational Age in Application Obstetrics are displayed on screen To confirm storing of these results in the report press Add The number of validated and added results for each measurement is indicated in the protocol list after each item in parenthesis When pressing Add after validation of the protocol measurement this measurement is included in the examination report In case of use without starting an examination user can use the protocol list to select available measurement perform measurement on the image and obtain an estimated Gestational Age in Application Obstetrics without selecting a Patient and opening an examination report The information can be stored or printed with the corresponding image without using the Report feature Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 26 sur 104 BECM Volume protocol measurements Make first two measurements Width and Height on a frozen image Defreeze find the second cut and freeze again Click Select to get first calliper of third measurement Depth and do as usually for making the measurement After validation the result of volume measurement is displayed If an examination is in progress this measuremen
67. io of 2 ED distances 76 Stenosis Surface IS Ratio of 2 surfaces ES Ellipsoidal volume Volume Volume 4 3 pixaxaxb ais the smallest axis 3D Volume Volume Volume 4 3 pi x W 2 x H 2 x D 2 Distance Ratio Distance A A B Distance B Surface Ratio Surface A A B Surface B APPLICATION GENERAL Mode PW Measure tool Measurement Doppler Auto RI Pl Speed Systole Speed Diastole S D Doppler Speed Speed Doppler Rate Rate APPLICATION GENERAL Mode M Measure tool Measurement Result Time and Distance Time and Distance Distance Time D T Heart Rate Rate Rate Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 95 sur 104 BECM APPLICATION Mode B CFM OBSTETRICAL Abbreviation Organ Author CRL Crown Rump Lenght Hadlock Hansmann Osaka Rempen Robinson Tokyo BPD Biparietal Diameter Chitty O O CFEF Hadlock Hansmann Osaka Tokyo GS Gestational Sac Rempen Hansmann Tokyo AC Abdominal Circumference Chitty drvd Chitty pltd CFEF Hadlock Jeanty Tokyo FL Femur lenght Chitty CFEF Hadlock Hansmann Osaka Tokyo HC Head circumference Chitty drvd Chitty pltd CFEF Hadlock Hansmann Head Area Head Area Chitty TAD Transverse Abdominal Diameter CFEF ThD Thoracic Diameter Hansmann FTA Fetal Trunk cross sec
68. iper for drawing arrows In Freeze mode Same key is used to delete the arrow in active imaging mode Use Clear to delete arrow in Freeze mode 30 F special function key used in combination with numeric keys 1 9 for annotation shortcuts see item 23 31 Contextual keys keys used to activate functions included in contextual menus 32 Cursors Up down left and right cursors to be used to scroll text lists for example in protocol measurement list to move cursor in a text field to adjust position and size of CFM box or to adjust position of PW gate 33 When the Chinese version is selected on the Setting page the key e activates and deactivates the Chinese input the key 4 activates and deactivates the larger space for numbers and other symbols 5 3 Screen icons An icon in the upper right part of the screen indicates the battery capacity When the device is connected to the main power supply the gauge is getting filled up Mp 100 The icon in the lower right part of the screen indicates the state of the memory on either the internal memory marked Exago or on a connected USB stick marked USB If the indicator is red the memory is full Exago Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 28 sur 104 BECM During storage of images or clips the following icons are displayed on the screen according to the storage media The arrow downwards indicates a storage on the internal
69. m risks of infections is essential for all health care institutions A treatment level corresponds to each risk level in order to obtain the needed level of microbiological quality 7 1 Cleaning and disinfection of the device The device has a low infection risk This risk level corresponds to the use of so called non critical medical devices which means devices which are not in direct contact with the patient The needed treatment for this type of medical device is a low level disinfection especially bactericidal The following disinfection solutions have been tested and their compatibility with the components of the device has been proved Cidex Cidex plus Cidex OPA It is strongly recommended to use one of these solutions in order to avoid any deterioration during the cleaning and disinfection procedure N WARNING The use of any other disinfecting solution than the ones indicated above is dangerous as it may damage the components of the device Check the list of specified agents carefully In order to ensure proper cleaning and disinfection please follow the following procedure 1 After every patient examination or as often as necessary wipe the keyboard and the external surfaces and casings of the device off to remove any traces of coupling gel 2 Switch off and disconnect the device together with all connected peripherals 3 Wipe the keyboard and the external surfaces and casings of the device with a clean soft cloth
70. mm 55 5 69 1 82 5 95 7 08 7 21 5 134 46 3 58 3 170 81 4 92 5 203 3 213 7 223 7 233 4 242 7 251 6 260 1 268 2 275 8 ND wo 289 6 295 8 301 5 306 7 311 4 315 5 319 wm ND N 324 4 50 mm 120 9 134 5 147 6 160 3 172 5 184 2 195 7 206 6 217 2 227 3 236 7 246 0 254 8 263 0 270 8 278 3 285 3 292 0 298 1 303 6 308 8 313 5 317 9 321 9 324 0 50 mm 68 1 82 1 N es N R f CD MA Manuel Utilisateur Exago 1_10 EN Page 79 sur 104 BECM HC Chitty Pltd FG age Aen E O TO 7 574 EE ni 350 547 E 781 EN m2 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 80 sur 104 BECM HC Hadlock FG er SD Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 81 sur 104 BECM OFD Chitty FG 20 0 Age 299 Version 1 du 03 05 2013 5075 mm 17 7 23 4 22 9 28 6 28 33 6 33 38 6 43 5 48 3 Cn Wi 57 6 62 1 66 5 70 8 74 9 N o 82 9 86 7 90 3 93 8 97 1 00 2 03 2 06 1 08 7 11 2 13 5 15 6 17 5 19 2 20 6 21 9 123 23 8 R f CD MA Manuel utilisateur Exago 1 10 EN Page 82 sur 104 BECM OFD Hansmann Identical weekdays som S E a E 50 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 83 sur 104 BECM TAD CFEF FG e pe EM E Do 98 E A TE 25493 85 L9 O
71. mpliant L A with the standard IEC 60601 1 Warning Read the user manual before using the device bearing this symbol Warning do not sit on the equipment Warning do not push the equipment if the castor wheels are locked ON OFF switch Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 6 sur 104 BECM Collect separately from other waste see European Commission Directive for mm electronic waste C CE Mark 2 3 Environmental conditions of use The device shall be operated in a clean atmosphere without dust and smoke The device is designed and tested be operated within this range of temperature 20 C to 60 C during transportation and storing 10 C to 40 C during operation The device is designed to be operated with a relative humidity range from 10 to 9576 including condensation The device is designed for the following atmospheric pressures 700hPa to 1060 hPa while in operation 500 hPa to 1060 hPa during transportation and storing N Warning Never use the device if these environmental conditions are not respected Stop operation of the device if one of these conditions is no more respected The device can be used in any room or place respecting these environmental conditions In order to ensure proper cooling of the device do not block the ventilation fans or obstruct the air exhaust Do not place the equipment against a wall
72. n activate CFM box Position control The Position adjustment can be done using the touchpad or the Cursor keys see item 32 Size activate CFM box Size control The Size adjustment can be done using the touchpad or the Cursor keys see item 32 Steering only active on linear probe Activate the Steering of the CFM box Select CFM box Steering angle by pressing and keys By default the Steering angle is equal to previous PW or CFM selected Steering angle value The Steering function is only available on linear probes Press Select to switch from Pre trace CFM to Active CFM mode operation and contextual menu Active CFM contextual menu includes PRF select PRF value 500 11313 Hz Displayed on screen with PRF label Wall Filter select the Wall Filter index 1 7 Rejection of movements from vessel walls and tissues With a high Wall Filter index slow speeds are rejected Displayed temporarily on screen with WFilter label MinVelocity select Min Velocity index 1 5 Rejects the color on slow velocities A high Min Velocity index cuts the color on slow velocities Displayed temporarily on screen with MinVel label Vessel Size select Vessel Size index 1 5 Optimisation of color sensibility according to the vessel size Index 1 for small vessels index 5 for big vessels Displayed temporarily on screen with VesSize label PacketsSize select the PacketSize index 1 3 Higher PacketSize index increas
73. n all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity of the Exago equipment Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 41 sur 104 BECM 11 Annex Ill Acoustic power Probe model C360V Mode B mode 2D TIS TB Non scan Maximum Index Value poa oie CSCS TT III pw f o 5 LLL amp IMnPags taazs o LS Em Lk z em IE IEA IES TE S S bom zaimaxipiacm 6 1 T ao E Does T Associated Hawi Me ACA A 9 8 3 acoustic A Y parameters praimaxpi 27 0 1 degatmaxpim 0 0 L LLL Ipa a at max MI information W cm 117 a This probe is not appropriate for trans cranial or cephalic application on a new born baby Probe model C360V Mode CFM TIS TB Non scan AAA Maximum Index Value ir oz ME T a MinPazs ltaa zs 2atmaxipiaem Lo 6 Lo deals e PR VERE Associated aus 25 26 oie acoustic DimAapt X 1 a J e parameters ES pose EA dus 02 do o Jd 1 prHz t9 J J 12 J O O Re po information W cm E Version 1 du 03 05 2013 R f
74. nsmann ISBN 0 387 15348 9 Springer Verlag New York P 36 Takashi Okai Department of Obstetrics and Gynecology Faculty of Medicine University of Tokyo Studies on Fetal Growth and Functional Developments Official Journal of the Japan Society of Obstetrics and Gynecology B CFM Tokyo ACTA OBST GYNEC JPN Vol 38 No 8 pp 1209 1217 1986 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P B CFM Chitty 35 43 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P B CFM Chitty drvd 35 43 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 57 sur 104 0 c 0 pas O Es 2 O Es a 0 Femur Length O O Fetal trunk cross sectional area J E O m m m mn m Q Gestational sac Q gt Head Area Q Te T O Head Circumference Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P HC FG B CFM Chitty Pltd 35 43 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age
75. or in a confined area this will result in a bad cooling of the equipment A minimal distance between walls and the device must be respected typically 30 cm N Warning Never block the fans or obstruct air exhaust this will lead to overheating of the device and compromise proper operation of the system 2 4 Electrical safety This equipment is compliant with IEC standard 60601 1 Safety for Medical Electrical Equipment According to the standard the equipment is classified as a According to the type of protection against electrical shock Class equipment b According to the degree of protection against electrical shock Type BF C According to the degree of protection against harmful water ingress IPXO device without protection against water ingress d According to the degree of safety of application in presence of flammable anaesthetic mixture with air oxygen or nitrous oxide Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 7 sur 104 BECM Device not suitable for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide e According to the mode of operation Continuous operation In order to ensure patient safety please observe these warnings gt Warning The equipment must be maintained in the exact same configuration as it was delivered by ECM It is forbidden to bring any change to the equipment without permission of ECM gt Warning The e
76. quipment must be supplied by using the provided power cord including a connection to ground gt Warning The equipment must be used with the power adapter supplied by ECM reference Protek PMP120 13 2 B2 The use of any other power adapter is forbidden The power adapter is considered as a part of the medical device gt Warning The equipment uses an internal Lithium battery The battery should exclusively be replaced in the equipment by the identical type of battery provided by ECM Replacing the battery by an incorrect type may cause excessive temperatures fire or explosion The Battery is a Lithium lon Polymer battery rating a voltage of 14 8 V and a capacity of 8400 mAh Warning All connected peripherals requiring power printer monitor USB peripherals or others must use an insulation transformer or must comply themselves with the standard EN 60601 1 1 Otherwise the global configuration can no longer be considered patient safe Ez Warning A risk of electrical shock may exist if the system is not properly grounded The system must be connected to the electrical power network by a three hole outlet with a connection to ground gt Warning Removing the power cord from the equipment may be used a s a safety action Always place the equipment in a situation where the operator can easily access to the power cord to remove it quickly and safely if needed gt Warning Version 1 du 03 05 2013 R f CD MA
77. r CFM selected Steering angle value The Steering function is only available on linear probes Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 20 sur 104 BECM Angle select position of the Angle correction marker The Angle value is displayed on screen with the label Angle and the marker is shown in the PW Gate Angle marker is displayed in red if the angle is not valid and in white if angle is valid Once the Angle marker is selected the frequency velocity scale in Active PW mode will include velocity labels To cancel Angle correction press Clear in Pre trace or active PW mode The PW gate Position can be adjusted using the touchpad or the Cursor keys see item 32 in the Pre trace PW mode Press Select to switch from Pre trace PW to Active PW mode Active PW mode contextual menu includes PRF select PRF value 2000 11313 Hz Displayed on screen with PRF label Baseline select the spectrum Baseline The frequency velocity scale is updated on the display Invert invert the frequency velocity scale The frequency velocity scale is updated on the display Audio select the audio output volume Filter select the PW Wall Filter 50 100 200 Hz Displayed on screen with WFilter label Power select the PW transmit power 50 100 Displayed on screen with Power label PW gain is adjusted with the Gain keys see item 16 Press Update to switch from Active PW mode to Pre tra
78. r Exago 1_10 EN Page 48 sur 104 BECM Probe model L738P Mode PW po mom On EE es O 25 a TT TT DE pw O poa o a a MinfPa zs Itaa zs zsm Lk Ep em S opo ooo LLL cem 0 0 0 o os pp zatmaxipiacm o 3 p ETE LTL G Associated fawMHz og o et 3443 616 m9 acoustic DimAapt X J o 9 09 _ ______ _ 09 a parameters Y__________ ______ ____ _ 43 43 y gs perez se O _ q A 22 9 deg at max Ipi cm Other Ipa a at max MI information W cm Probe model L738P Mode M IL E E E AR TE bett pm 1 zm eT pm sol to E Fee Bm rt Izatmxli aeom ST Idegz cm 12 Associated fawfMHz oe 6 16 S 6 16 a acoustic Dim Aapt X 1 1 09 0 9 S ea parameters A EE dus 5 184 L lotHz Y 520 J J J A J 4 a aoea 35 Other Ipa a at max MI information W cm Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 49 sur 104 BECM Mode B Probe model E610A mode 2D IS TB Non scan a 1 Maximum index Walue I d 08 Min Pa zs lta a zs zs cm zaumaxpiacm 3 0 pp tim E E O S S Associated fawMHz________ 6 29 629 ____ ____ ___ _ y acoustic DimAaptX_____ __________ _ 092 _ ______ _____
79. r folder Hospital name selection of the Hospital Name as a free text The Hospital Name is displayed on screen User Name selection of the User Name Doctor name as a free text The User Name is displayed on screen Patient Identification selection of patient identification by patient name or Patient ID Language selection of system language When the Chinese version is selected the key activates and deactivates the Chinese input the key 4 activates and deactivates the larger space for numbers and other symbols Image format selection of stored image files uncompressed bitmap compressed jpeg raw data image and or Dicom format images DICOM only allows saving the images only on Dicom format visible only when the Dicom format is selected M PW Scroll speed duration in seconds of scrolling M PW display 2 4 or 6 seconds 4 sec by default M PW Refresh refresh frequency of B image every 1 2 or 4 M PW scrolls 1 scroll per default Tools Distances selection of automatic distance measurements in sequence If this option is active once a distance measurement is completed the system automatically displays the first calliper of the next distance measurement Active by default Tools Freq Focus Auto Select selection of AutoSelect function When enabled B mode transmit focus and transmit frequency are selected automatically by the system depending on image depth These functions can still be adjusted manually during the a
80. rage is used To enable the storage on the Dicom storage server the Enabled checkbox should be ticked The Ping key allows in case the network authorizes it to check IP connection to the server The Echo key allows to check the Dicom connection to the server using Port and AE identification Log enabled Information about the network communication To be used in case of problems e Print Menu Host Print server IP address Provided by the network administrator Port Print server Port default value is 104 Provided by the network administrator AE Print server Application Entity name Provided by the network administrator Local AE Exago system Application Entity name Allocated by the network administrator Interpretation image format Pallete by default If not accepted by the server select RGB Red Green Blue or Monochrome no color Orientation to be selected as portrait or landscape To enable the print on the Dicom print server the Enabled checkbox should be checked Print Pressing the Print key black square located on the right of the space bar will print the image on the Dicom storage server Printing of images is possible during the examination or when the images are stored in imag format The Ping key allows in case the network authorizes it to check IP connection to the server The Echo key allows to check the Dicom connection to the server using Port and AE identification User Protocol access
81. rning For safety and maintenance reasons never disconnect a probe from the device without freezing the system first 2 8 Probe information 2 8 1 Probe types and corresponding applications The probes provided with the Exago device are the following C360V Convex probe central frequency 3 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular C360A Convex probe central frequency 3 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular C360R Convex probe central frequency 3 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular L738P Linear probe central frequency 7 5 MHz This external probe is used for the following applications General vascular pediatrics small parts breast testis etc C614P Micro convex probe central frequency 6 MHz This external probe is used for the following applications General vascular small parts pediatrics E610A Endo cavity probe central frequency 6 5MHz This probe is used through the rectum or through the vagina for the following applications General gynecology obstetrics urology Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 11 sur 104 BECM E610R Endo cavity probe central frequency 6 5MHz This probe is used through the rectum or through the vag
82. s can possibly occur with an increase of the maximum rarefaction pressure The TI index thermal index is related to the tissue temperature rise and corresponds to the ratio between the total acoustic power and the acoustic power required to raise the tissue temperature by one degree Celsius There is no simple model to represent the temperature rise in all conditions and for all type of tissues A TI index of 2 represents a higher temperature rise than a Tl index of 1 but cannot be considered as a temperature rise of 2 C The Tl index is intended to advise the user of a possible temperature rise in a specific area 2 1 4 Accuracy of MI and TI parameters display The mechanical and thermal indexes are displayed permanently and explicitly on the screen in the Upper right corner See chapter 5 2 During the use of the device the operator must survey the effect of the controls which are influencing the acoustic power and if necessary write down the values of the indexes As indicated above the operator must permanently try to maintain the indexes at their lowest possible level and to reduce the exposure length The preciseness of the display of the mechanical and thermal indexes MI and TI is at 0 1 2 2 Safety symbols Please note the meaning of the following safety symbols Symbol Signification E q Type BF patient applied part B body o F floating applied part The probe complies with the class BF Medical Electric equipment co
83. s no risk for them to fall or move in unexpected ways gt Warning When moving the device with the Exago trolley take care of avoiding any mechanical shock or collision due to the important inertia of the equipment gt Warning When closing the locking system on the Exago trolley take care of avoiding pinching your fingers between the locking mechanism and the upper part of the equipment Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 15 sur 104 BECM 4 Getting started 4 1 Connection and disconnection of probes To connect a probe put the probe connector in the opening provided for this purpose Turn the locker situated in the middle of the connector with a slight pressure in order to engage the locking mechanism When the locking mechanism is engaged make a quarter turn so that the probe is connected After connecting a probe always place the probe in a safe place in one of the probe holders if the system is used with its trolley in order to avoid any damage of the probe due to a shock or falling down The probes can be changed during the examination without restarting the device To disconnect a probe make a quarter turn in order to unlock the connector Take the connector out of the device and store the probe in an appropriate place protected from shocks N Warning Before disconnecting the active probe make sure to freeze the image When starting the device always make sure
84. sateur Exago 1 10 EN Page 13 sur 104 BECM Neither the ultrasound coupling gel nor the external probes are intended for use on a damaged skin 2 8 5 Surface temperatures The probes provided with the device are compliant with the security standards concerning surface temperatures The probes have been designed in order to never let the surface temperature exceed 41 C A Warning The Exago device has not been designed to be used together with a high frequency surgical device A risk of patient burn might exist in case of failure in connection of the neutral electrode of the surgical high frequency device 2 9 End of product life of the device At the end of life of the device due to a reject or a definitive end of use the device must be recycled Take care of bringing the device to a certified recycling center or return it to the distributor The distributor s address is found on the first page of this manual Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 14 sur 104 BECM 3 Installation of the equipment The Exago device must be installed on site by a person authorized by ECM A Warning Never try to open the equipment Only an ECM qualified customer service engineer is authorized to open the system and service it gt Warning After installation with the Exago trolley check that the mechanical components optional LCD screen additional screen arm are properly attached and that there i
85. t 1 cm Aaprt gt 1 cm TIC E 13 29 ay Maximum Index Value 1 17 E IE 72 27 L 72 27 LT zs m Do E pp 25 pp AA ME IE CI EE Associated LS MIEL og TI 6 16 ce 9 NENNEN L L L E z om A S y a E a acoustic Dim Aaprt X D 992 parameters Lg a Do 1 o 5120 f o o pr at max D mt Lo A dea at max ler om JA Ipa a at max MI information W cm Probe model E610R Mode M NECEM NN HR Nonscan Index label Eine Aaprt lt 1 cm E 1 cm Maximum Index Vae 052 ________ _ 077 gt EE Pw Ja H E a 7 MinPazs taa z oo _ Iz cm z em 1 1 Too IE TS E wen OOOO YO Yoo poor zatmaxlpiacm__ ___3__ ____ _ _ degbo em Associated LS MIEL og ________ __616_ ________ 646 a acoustic DimAapt X oe ose a parameters E Te Tea EE E EOS eriz ST IS S S a G O o e cl cl ee deg at max pi em 1 Other Ipa a at max MI information Rem 4 Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1_10 EN Page 53 sur 104 BECM Probe model C614P Mode B mode 2D po mom Maximum Index Value 12 ora pp T s pra MPa 277 1 1 IR s ___ _ S Min Pa s ttaak s ____ 1 pp pasea AA bpm ooo S 12 LL E em IS TEN IE LLL G zaimaxipiacm 3 _ deg on Associated fawMHz 612 f
86. t Area Osaka APAD Ant Post Abdominal Diam Merz Trans amp Ant Trunk Diam Tokyo Clavicle Clavicle Yarkoni NT Nuchal Tranlucency OFD Occipito Frontal Diameter Chitty Hansman EFW ac fl Estimated Fetal Weight Hadlock EFW bpd ac fl Estimated Fetal Weight Hadlock EFW hc ac fl Estimated Fetal Weight Hadlock EFW hc ac fl bpd Estimated Fetal Weight Hadlock EFW bpd ac Estimated Fetal Weight Shepard EFW bpd thd Estimated Fetal Weight Hansmann EFW ac Estimated Fetal Weight Cambell EFW bpd fta fl Estimated Fetal Weight Osaka EFW bpa aptd ttd fl Estimated Fetal Weight Tokyo FL HC Ratio HC AC Ratio FL AC Ratio FL BPD Ratio Amniotic Fluid Index IOD Inter Orbital Diameter Cl Cephalic Index Facial Angle Facial Angle Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 96 sur 104 BECM APPLICATION OBSTETRICAL Mode PW Abbreviation Organ Measure tool Author Fetal Heart Rate Fetal Aort Doppler Auto Schaffer Mai Rate Left Uterin Doppler Auto Schaffer Rate Right Uterin Doppler Auto Schaffer Rate MCA Middle Cerebral Artery Doppler Auto Mai Schaffer Rate UA Umbilical Artery Doppler Auto Mai Schaffer Rate Doppler Auto RI PI Heart Rate Rate APPLICATION OBSTETRICAL Mode M Abbreviation Organ Measure tool FHR Heart Rate Fetal Aorta He
87. t can be added to the report pressing Add Flow measurement in PW available in General and Vascular applications Add the angle before freezing Select the Flow measurement tool Click on the touchpad to validate the speed measurement on the PW spectre Make the diameter measurement and the calculation of the flow will be automatically displayed IMT Intima Media Thickness measurement available in General and Vascular applications On a frozen B image with the Intima visible select IMT in the protocol list Adjust the position of the measurement box with the trackball Click Select to switch between position and size adjustment The white and green lines indicate the intima media thickness and the measurement result is automatically displayed on the screen 25 Report access to Report menu allowing to review images clips and examination reports from USB device if connected or from internal system memory Text reports can be reviewed as well as stored images and clips When no examination is under progress Report will display the following e Export USB exports selected data image clip patient complete examination or report on an external USB device e View display selected items from the menu main list text report images or clips For an image or a clip See item 13 on Review For a report see below like for a report under progress e Rename rename the selected data image or clip e Delete delete the selected data im
88. tch from one image to another in Dual B 11 gt in Freeze mode move to next Cineloop image Current image index is displayed on screen 12 Store store current image on external USB device if any or in internal memory 13 Review access to Review menu for reviewing stored images or clips from external USB device or internal memory System will explore the USB in priority before exploring the internal memory In order to access to internal memory remove any connected USB device Review display includes an Image List and a Clip List in which the file to be reviewed should be selected using Touchpad Review contextual menu includes e Load display the selected image or clip For a loaded image in format bmp or jpeg see item 23 Previous display the previous image in the image list Next display the next image in the image list Rename rename the selected image Delete delete the selected image Back return to the upper level menu 0 lt O O For a loaded image in format imag raw data format see item 23 o Cineloop menu possibility of making new measurements or adjusting existing measurements in post processing and storing of this Press Freeze to exit the cineloop mode For a loaded clip First image display the first image of the selected clip Play Pause play or pause the reading of the selected clip Last image display the last image of the selected clip Store clip Store current clip O O O
89. th all attached reports images and clips o Previous Return to the New Patient page e New Patient create a new patient in the patient list Patient data are typed by user in the Patient box Version 1 du 03 05 2013 R f CD MA Manuel utilisateur Exago 1 10 EN Page 27 sur 104 BECM In the Exam box select the Application and the protocol Factory or User protocol see item 23 to be used for the examination In OB application the patient s LMP date can be entered This date will be used for the reference gestational age To validate patient data and confirm patient creation press Exit or proceed to start an examination e Start Exam start an examination and opens an examination report All stored images clips and protocol measurements will be included the current report e End Exam stop current examination and closes examination report e Exit exit from the Patient menu 27 Text In Freeze mode display a text field for writing an annotation on the current image Shortcuts can be used to display user pre defined annotations in the Settings menu by pressing F function key and one numeric key F and 1 for example See item 23 Free text can also be entered If the option Annotations Restore last annotation in the Setting menu is active the last entered text will automatically be displayed in the Text field Press enter to validate 28 Picto not active 29 Arrow display an arrow in active imaging mode or a call
90. to have a probe connected on the connector The label of the connected probe label is displayed on the screen top right of the image 4 2 Use of Exago trolley If the equipment is used with the Exago trolley check that a probe is connected to the right hand side connector To start the device use the same procedure as below for the Exago equipment 4 3 Starting of the device N Warning Only the power cord supplied by ECM with a ground connection must be used to power the device Never use a power cord without proper ground connection To start the equipment turn on the power switch situated on back panel of the device Then wait until the system starts and displays the user interface on the screen The Exago equipment starts in B mode with the probe connected on the probe connector If no probe is connected to the probe connector the system will display a label No probe In this case connect a probe to the connector and press Freeze or restart the equipment To stop the equipment press again the power switch situated on the back panel of the device A shutdown procedure will be performed until the complete stop of the equipment 4 4 Battery operation The Exago battery can be removed from the equipment by pressing the two clips located on the rear of the product When inserting the battery back in the device check that it is securely fastened When the device is powered on the main network the battery is charging whatever the

user guide

Contents

Download Pdf Manuals

Related Search

Related Contents