User Manual - Breast Life srl
Contents
1. A MODEL B SERIAL NUMBER C DATE OF MANUFACTURI D INPUT supply voltage MODELLO Aura NUMERO DI SERIE 55910A0 DATA DI FABBRICAZIONE 03 2009 Breast Life BREAST LIFE S r l Piazza San Martino 1 40126 BOLOGNA ITALIA Rev 06 03 2010 Q D ER O 0 Er je UONEIYNUOP 2 0 Package contents 2 1 Accessories provided 2 2 Optional accessories U W O W D O e D er oO Package contents 2 0 Package contents The device packaging contains the following items If any of the package contents are missing or damaged please contact your retailer 1 AURA 2 CAMERA 3 AC CABLE 4 PLATES 4a PLATE 33 5 C 92 3 F COLD BLACK FRAME 4b PLATE 32 C 89 6 F WARM WHITE FRAME 5 CAMERAADJUSTMENTKEY 6 CD R USER MANUAL Package contents zB U VY O 0 Le OD O je P OD ce Rev 05 07 2009 3 nN re ou c OO O 19 ne G Q 2 1 Accessories provided In addition to the items provided the packaging includes the following accessories If any of the packaging contents are missing or damaged the conditions referred to above apply 1 CAMERA 2 2 Optional accessories Inclusion of the following device in the package can be re quested as an accessory If any of the packaging contents are missing or damaged the condition2. 4 0 Operating sequence Having installed the device as described in chapter 03 Instal lation before using the AURA the following checks must be made Check that the LED L1 see 3 2 4 Preparing the device is green Check that the plate 9 is mounted correctly on the support and that it is the correct type visualisation power Check the direction of the camera 10 in relation to the plate alignment If necessary adjust the locking screws V under the support using a suitable wrench see pack Loosen them as far as necessary to direct the camera in rela tion to the plate They must be adjusted in such a way that the area to be photographed includes both the plate area and the LEDs underneath as shown by the dotted lines in the illustration When adjustment is com plete retighten the screws At this point the lens cover can be removed and the SL diagnosis operations can be performed VISUALISATION POWER The industrially encapsulated liquid crystals have various levels of sensitivity as a result of which they react to the heat received from red to violet according to various ranges This ensures that the plates have different visualisation powers Plates calibrated in various ways must therefore be prepared it Is up to the operator to select the one most sultable to the case In question ALIGNMENT Alignment is simply a matter of adjusting the angle of the camera in relation to
3. The quality of the electricity supply system must be the usual level for commercial or hospital premises If the user requires continuous operation during power cuts it is advisable to equip the AURA with an uninterruptible power supply UPS or a battery The device requires particular precautions regarding the EMC and must be installed in accordance with the EMC information contained in the accompanying documentation Do not use the device in the proximity of mobile and portable radio communication equipment in order to avoid any distur bance to the behaviour of the medical appliance 3 0 Warnings and precautions for use asn papuaju 0 5 Q 3 0 1 Instructing personnel working with the machine Use of the medical device must be restricted to medical per sonnel these personnel due to their experience and profes sional level will be able to make the correct choices in order to achieve the desired effects We recommend that all operators and support personnel are provided with adequate instruction on safety standards and that a suitable instruction and or update programme is adopted 3 0 2 Safety notices Knowledge of the general safety instructions and applicable law enables the device to be used safely and correctly This manual provides important information on the safe use of the machine particularly safety instructions which must be followed by all persons involved in the use of t
4. image This consistency of the image even during pregnancy can be useful for identifying neoplasias of the breast related to preg nancy which is very difficult to do in any other way Breast radiotherapy after breast cancer makes it difficult to produce a correct diagnosis on the remaining parenchyma to assess any local relapses for at least six months as the oedema and the inflamed state caused by radiotherapy mask the presence of new tumour vessels Cream Ultrasound gel The presence of body cream or ultrasound gel may compro mise the correct diagnosis as it can create a filter between the plate and the vascularization of the mammary gland The DATG technique can be used at any point during the menstrual cycle asn papuaju asn pepuejul 4 0 Usage 4 0 1 Description of the device 4 1 Operating sequence 4 1 1 Area identification 4 2 Re use procedures 4 3 Disposal 4 0 Usage 4 0 1 Description of the device Having removed the device and accessory parts from the packing place it on a previously prepared surface The AURA device consists of the following parts 1 BASE UNIT 14 FAN SWITCH 2 CHARGER BASE UNIT 15 LED SEQUENCE 3 SLEEVE UNIT SWITCH 4 BATTERY UNIT 16 AIR FLOW INDICATOR 5 ARM BODY UNIT LED 6 FAN 7 SUPPORT 8 PLATE UNIT 9 PLATE 10 CAMERA 11 PLATE CONTAINER 12 AC SOCKET 13 USB SOCKET Rev 06 03 2010 3
5. damage Cover the device with a sheet or something similar 4 3 Disposal At the end of the operating life of the device all its parts must be disposed of in accordance with the applicable legislation in the user s country regarding the disposal of electromedical instruments and equipment 5 0 Maintenance v eh D Q 5 0 Maintenance To ensure efficient operation and maintenance of the device in conditions of total efficiency and safety the information in the table below must be complied with EVERY 2 FAN CLEAN HR Re OPERATOR ASPIRATOR CHECK BAT on TERY SUP OPERATOR PLIER Maintenance MULTIPUR OPERATOR POSE DETERGENT ON EVERY PLATE 6 0 Technical data 6 0 1 General specifications 6 0 2 Device specifications OD 2 O Q W ch pa Technical data 6 0 Technical data 6 0 1 General specifications SPECIFICATIONS 24 8 L X 20 8 H H1 22 8 X 13 7 S
6. O gt ae lt O je LU F o O z lt DYNAMIC 1 0 Manual identification 1 1 Manufacturer identification 1 2 Product identification 1 3 CE marking Q D mp O 0 O 2 1 0 Manual identification Please read this manual carefully before use In particular all employees assigned to use of the device must read the instructions for using it safely In the event of any difficulty please contact the support team Identification User manual code Date of issue VALIDATION COMPANY ROLE SIGNATURE DATE 1 1 Manufacturer identification Please read this manual carefully before use In particular all employees assigned to use of the device must read the instructions for using it safely In the event of any difficulty please contact the support team Q D mp O Q O 2 Identification 1 2 Product identification The Aura medical device is an electromedical device The device conforms to the requirements of Directive 93 42 EEC Appendix Il Model Aura Version 55910A0 Device category 2A Manufactured by BREAST LIFE S R L BREAST LIFE S R L PIAZZA SAN MARTINO 1 40126 BOLOGNA ITALIA Identification 01 i 1 3 CE marking The plate bearing the CE marking is placed where shown in the illustration as per the specifications in Appendix XII to Directive 93 42 EEC The plate shows the following in the order below
7. RAME The temperature difference is very important To examine young patients the colder 92 3 F plate is used while when visiting patients in or close to menopause it is preferable to use the more sensitive 89 6 F plate see CHAP 01 Paragraph 2 0 Contents of the Package The plate is positioned on a supporting device which also has the following functions cooling in order to eliminate the disturbance action to the diagnosis procured from superficial veins Rev 06 03 2010 23 2 D 2 el CD Q c oO D It is important to observe certain precautions when handling the plate both during and after use in diagnosis procedures To avoid any damage we recommend that at the end of the process you replace the plate inside the compartment provided in the base of the device When handling the plates we recommend that you hold them by the external frame and avoid touching the opaque internal part A Insert them in the corresponding tray positioning them as il lustrated in the figure A ATTENTION DO NOT EXPOSE TO EXCESSIVE HEAT SOURCES Intended use Q OPAQUE SIDE FACING UP SHINY SIDE FACING DOWN 3 3 Contraindications As it is not a radiological technique it can even be used during pregnancy The image which is obtained is an image with a greater scope but without the presence of new vessels at the end of preg nancy and breast feeding the image will return to the basic
8. disconnect the supply cable from the power grid Fix the camera in place then hold it firmly and rotate it 180 Open the cover and insert the battery BF in the housing ensuring it is the right way up To ensure it is in place correctly follow the instructions in the illustration Close the battery housing cover until you hear a click To remove the battery you need to press the block BK shown in the illustration If extended use of the camera is intended it is advisable to have a second battery in reserve asn papuaju 0 5 Le Q MOUNTING THE CAMERA Carry out the installation as described below Insert the attachment AT under the camera 10 in the ap propriate guides G in the support by first pressing the end of the lock F then inserting the camera as shown in the illus tration until you hear a loud click to indicate that mounting is complete CONNECTING THE CAMERA S USB CABLE The USB cable is located in the lower part of the support in the position indicated in the figure Open the lock to access the multi connector then insert the end of the cable into the socket 2 D 2 Q D Q c D lt b Yp Le po lt b vd Intended use PLATE ASSEMBLY Grip the plate 5 and position it on the support 8 where the magnets M are located making
9. ed with suitable straps and adhesive tape for packing Protective moulds are provided inside to avoid any damage All lifting and transport operations must be carried out in ac cordance with the applicable accident prevention instructions The packaged equipment must be moved using appropriate means of lifting and transportation transpallets forklift trucks etc The personnel involved must wear all the accident pre vention protective equipment required during these operations ANumPORTANT Follow the instructions in the pictograms on the outside of the packaging BREAST LIFE S R L cannot be held liable for damage to per sons or property arising due to total or partial failure to comply with the appropriate precautions to be applied in lifting and transporting the package 3 1 Packaging lifting and transport asn papuaju Intended use Place the package in a site which facilitates unpacking of its contents positioning it as indicated on the pictogram at A Cut the straps 1 using suitable tools and remove the adhe sive tape on the upper part Open the packing strips and take out the contents with the top covering and the lateral guards still in place Separate out the packing residues and the packaging itself then comply with the rules applicable in the country of use regarding disposal of packaging waste 7a Le Le c Med 10 Rev 06 03 2010 3 2 Insta
10. he device Attention must be paid to all the applicable accident preven tion rules in the country and site where the device is installed and used and these rules must be followed 2 D Q D Q oO D 3 0 3 Obligations of personnel working with the machine Before starting to operate this medical devcie all persons involved undertake to pay attention to all accident prevention rules applicable to the environment in which they are operating carefully read this manual in relation to safety aspects 0 5 Q Le 3 0 4 Safety measures for use Only medical personnel may use the device Inexpert or not fully trained persons may use the device only if they are accompaned by an expert and under the responsibil ity of the expert Only technical support personnel may intervene in the elec tronics If intervention is required on the electronics of the device at least one more support person must be present Specific accident prevention labels are placed on the guards on the areas where particular dangers apply asn papuaju 3 0 5 Safety information This user manual must always be easily consultable at the site where the device is in use In addition all signs and information labels must always be kept in good condition 0 5 Le je The AURA device is provided in a special cardboard pack with a wooden base all clos
11. in the plate holder tray see CAP 03 Par 3 2 4 Preparing the PLACCA ANGIOTHERMOGRAPHIC PLATE device Connect the USB cable to the socket 13 see 4 0 1 De scription of the Device located in the base of the device then transfer the images to the patient s file on the computer Usage 4 1 1 Area identification The series of LEDs on the plate unit enables the photographic sequence of the four areas of the breast to be established as they progressively light up Each LED corresponds to an area of the left breast and the right breast The key below shows the correspondence between the LEDs and the four areas of the breast L2 LEFT SIDE OF BREAST L3 LEFT FRONT OF BREAST L4 RIGHT SIDE OF BREAST L5 RIGHT FRONT OF BREAST 10 Rev 06 03 2010 4 2 Re use procedures Once the operational procedure is complete the procedures for maintaining the device in conditions in which it can be re used fully efficiently must be followed Special attention must be paid to how the operator is to a check the integrity of the device and its components power cable applied and electrified parts etc b clean the device and its applied parts If a period of extended inactivity is planned the AC power cable must be disconnected from the power grid and from the device itself see 3 2 4 Preparing the device ELECTRICAL CONNECTION Then place it in a dry obstacle free place in order to avoid any
12. llation 3 2 1 Customer responsibilities Before installation the area and site where the device is to be located must be properly prepared The designated site must ensure correct installation and be large enough to enable all the phases of use The socket for connection to the power grid must comply with the requirements of the country where the device is being installed Finally a suitable operating environment must be provided Details on this are provided in the following paragraphs asn papuaju 3 2 2 Electrical connection The device must be connected to the electrical system in ac cordance with the applicable electrical safety requirements In accordance with the applicable European standards the device is normally provided with a supply cable and Schuko type plug as per the CEI 23 50 standard 0 5 Le je 3 2 3 Temperature and humidity To ensure that the device functions correctly the temperature must be between 50 and 104 F 2 D Q D Q c ON D 7a Le Le c wd intended use 3 2 4 Preparing the device Having taken the device out of the covering and its protective equipment place it at the intended site The site must have a perfectly stable flat base and there must be an AC socket for the power supply In addition the position of the device must ensure that it is easy to use ELECTRICAL CONNECTION Co
13. n proportion to the heat received due to their particu lar molecular structure The cholesterol liquid crystals are organic crystals derived from cholesterol and their spiral molecular structure expands and contracts as the temperature changes These crystals can therefore be formulated and calibrated to change colour at specific temperatures They reflect the light that they receive in a series of colours in sequence namely red green and blue The microencapsulation process encloses the liquid crystal in microspheres thereby protecting it from external agents The microencapsulated liquid crystals always show the change in colour in the same way and order with speeds that vary depending on the extent of the temperature scale The available precision is 32 9 F for medical products Rev 06 03 2010 Intended use Available temperatures range from 22 F to 248 F The microencapsulated liquid crystals always assume the same colouring at the formation of the image and in a reversi ble way thereby allowing the use of these indicators repeate dly with precision and consistency The possibility of detecting even minimal differences in temperature of any given body by applying an ELC coated plate to that body is extremely useful in the diagnosis of even minimal variations of the organ examined The plates supplied as standard are of two temperatures 92 3 F PLATE COLD BLACK FRAME 89 6 F PLATE WARM WHITE F
14. nnect the supply cable see package to the AC socket 12 and to the power grid socket Press switch T to turn on the device Check that the LED L1 on the plate unit 8 comes on BATTERY RECHARGING Charge indicator RED LED charging in progress GREEN LED recharging complete ORANGE LED running out of battery recharging time approx 3 hours and 30 minutes z L LON SD wr 14 Rev 06 03 2010 Check that the sleeve unit 3 is properly placed in the seat of the recharging base unit 2 and fixed in place with the appro 2 D 2 Q D Q c Oo D CAMERA The AURA device is provided with a camera and a support for it Proceed as follows to prepare it for operation BATTERY CHARGING Inside the camera package see accessories provided you will find the camera battery BF the battery charger CB and a supply cable for it 3 Prepare the parts as shown in the illustration then connect the plug to the power grid and wait until the battery has fully charged Intended use A BATTERYR EC CH i A RGI A ING _ Charge indicator RED LED charging in progress GREEN LED recharging complete ORANGE LED running out of battery recharging time approx 3 hours and 30 minutes INSERTING THE BATTERY INTO THE CAMERA Having completed the charging process remove the battery BF from the battery charger and
15. of the LEDs present on the plate support must light up Pressing the button 15 in sequence illuminates the next LED and extinguishes the preceding one This enables the operator to monitor the photographic se quence see Par 4 1 1 Area identification We recommend positioning a light source behind the doc tor carrying out the examination Rev 06 03 2010 EXAMINATION WITH DYNAMIC ANGIOTHERMOGRAPHY 1 Accurate anamnesis 2 Clinical examination of breasts and lymphoid stations 3 Position the angiothermographic plate and evaluate the sequence and strength of the angiothermographic signs 4 Cool 5 Position the plate again and evaluate the angiothermo graphic signs again 6 Carry out a mental subtraction 7 Evaluate Symmetry counter lateral proportionality Regularity of the peduncles a Form pointed termination b Location in the anatomic quadrant of the peduncle c Appearance of the image The image allowing for subtraction of the venous back ground noise 8 Correspondence between CLINICAL DYNAMIC ANGIO THERMOGRAPHIC examinations 9 Correspondence between MAMMOGRAM ECOGRAM DYNAMIC ANGIOTHERMOGRAPHIC examination Once the diagnosis has been completed reposition the arm by inserting the handle into its housing in the front of the sup port recouple the arm again using the lock Remove the plate from the support grasping it by its frame and replace it
16. s referred to above apply U VY O W D O e D er o s u uo 9peyo5ed 3 0 Warnings and precautions for use 3 0 1 Instructing personnel working with the machine 3 0 2 Safety notices 3 0 1 Obligations of personnel working with the machine 3 0 4 Safety measures for use 3 0 5 Safety information 3 1 Packaging lifting and transport 3 2 Installation 3 2 1 Customer responsibilities 3 2 2 Electrical connection 3 2 3 Temperature and humidity 3 2 4 Preparing the device 3 3 Contraindications asn papuaju Intended use Intended use The AURA device enables mammary injuries to be diagnosed using the dynamic angiothermographic technique The technique is not a replacement for mammography but is a supplement to it to increase the sensitivity of diagnosis in breast treatment It is a non invasive technique which can be applied to women of any age and it is readily repeatable painless and risk free The AURA is a genuinely promising diagnostic instrument for assessing even young patients with high mammary gland den sity and for preventive purposes The AURA device must only be used in a suitably equipped hospital department or doctor s surgery The doctor using it is responsible for the proper safe use of the device with particular reference to the following points the device is designed for a permanent electrical installation
17. sure beforehand that the opaque part of the plate is facing in the direction of the camera lens Check that the plate is fitted correctly on the support if it is not repeat the operation SHINY SIDE DIRECTION OF THE PATIENT A WARNING IN HANDLING THE PLATE PAY PARTICULAR ATTENTION NOT TO TOUCH THE OPAQUE SIDE A OF THE FILM WITH YOUR HANDS GRIP IT HOLDING IT BY THE FRAME AS SHOWN IN THE FIGURE 20 Rev 06 03 2010 POSITIONING DIAGRAM 2 D Q D Q oO D lt b nN Le Q Le vi 22 Intended use ANGIOTHERMOGRAPHIC PLATE The angiothermographic plate consists of a thin and rigid support that stretches a very thin sheet of plastic material on which a layer of black paint and a layer of cholesterine liquid crystals are applied The entire assembly has a thickness of a few hundredths of mm In this way the plate can rapidly acquire the cutaneous heat and cool down just as quickly until it returns to the basic condi tions The formation and the disappearance of the image which take place by supporting and distancing the plate on from the breast occur in fractions of a second Manufactured in this way it is also capable of maintaining a spatial resolution constantly lower than 0 03 0 39 Inc during the whole time required for reading interpreting and recording the image This capability is provided by liquid crystals that partially refract the light i
18. the plate or more precisely adjusting the field of the camera in relation to the area to be photographed It is performed during assembly by the manufacturer After adjustment the adjustment screws V under the support are tightened and locked with paint It may be the case that due to settling expansion as a result of variations in temperature etc the alignment is no longer optimal and must therefore be reset to the factory settings Rev 06 03 2010 Usage Uncouple the arm by releasing the lock then lift it off the charging base unit by grasping it with your left hand Move the arm towards the breast then press button 14 to activate the cooling fan and the LED 16 which illuminates the area where the cooling air flow is to be directed by a beam of light Cooling must last for a period between 5 and 15 seconds Having created the right conditions place the plate on the breast the press button 15 with your right hand to activate the LED 12 see Par 4 1 1 Area identification and press the camera button again with your right hand to take the photograph Proceed in the same way in accordance with the sequence described below Normally the procedure involves examining the lateral quad rants of the right breast followed by the front quadrants fol lowed by the front quadrants of the left breast then the lateral quadrants Each time a photograph is taken it must correspond to a quad rant and one
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