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USER'S MANUAL - Doctorshop.it

1. The deterioration of waveforms as the obstruction progresses is similar the one relative to photoplethysmography see 21 2 01 274 H 81 Atys m dical USER S MANUAL BASIC 21 4 Understanding the ABI test You can use the following diagnostic guidelines based on Buchbinder and Flanigan Arteril Disease of the Lower Extremities for interpreting the index Condition ABI Normal Above 0 96 Mild obstruction 0 71 0 96 Moderate obstruction 0 31 0 70 Sever obstruction 00 0 30 21 5 Understanding the segmental pressure test The following criteria indicate that further examination is necessary e The upper thigh pressure should be 10 mmHg greater than the Brachial pressure If it is less it may indicate an obstruction e Pressure difference between adjacent cuff sites on the same leg such as the lower thigh and calf that exceed 20 30 mmHg may indicate an obstruction Also pressure differences between cuff sites at the same level on opposite legs that exceed 20 mmHg may indicate an obstruction e A pressure difference of over 30 mmHg over the entire leg from the upper thigh to the ankle may indicate an obstruction The examination of the waveforms recorded during a segmental PVR Pulse Volume Recording test is useful to confirm the results of the segmental pressure test If the patient is symptomatic but the pressures appear to be normal you may want to exercise the patient 21
2. e eee Right 10 mm I tee eweee I Filter Artery 1 D a He Scale 500Hz 10cm s Ft eec s cm S pe ary Po ook 76 Partially obstructed bi directional waveform Note the distinct upstroke and downstroke systole but diminished waveform height partial loss of the flow reversal and loss of the arterial wall s elastic rebound peak 01 274 H 78 A tys m dical USER S MANUAL BASIC ar To E 37 12 02 ONU 1mn28s STD le A R E NETT z EAR DOP 8N Posterior Tibial ERM Pe free een Right Filter D 10 mn RE m N EA ai V Speed 0 4s cm eae A nn nee monks F e i Le ia CE Increasingly obstructed bidirectional waveform Note the rounding of the upstroke and downstroke during systole and diminished peak height complete loss of the flow reversal and complete loss of the arterial wall s elastic rebound CR TE im 3 31 12 02 ali eee fs ETT l PREEN DUP EN Posterior Tibial EVAS ieee RIRE Fee mom a Rigul i Filter 3 pe es D 10 mm Feu PROS ae Scale 500Hz 10cr s Speed 0 4s com a a Pas s J a00 pi Pain F ia A F 50 50l a Severely obstructed bidirectional waveform Note the dramatic loss of peak height during systole 01 274 H 79 USER S MANUAL Atys m dical BASIC 21 2 Arterial photoplethysmography The following series of PPG waveforms r
3. panel is left and the acquisition screen is displayed Press Null to exit the Select vessel panel without selecting a new vessel 01 274 H 65 A tys m dical USER S MANUAL BASIC 13 3 Examination To select the type of the examination the following operations are to be performed Press the QuickButton from the acquisition screen to display the configuration panel Turn the QuickButton to select Examination if not frozen Press the QuickButton to validate Turn the QuickButton to select the examination Press the QuickButton to validate Once the examination is validated the menu is left and the acquisition screen is displayed Press Null to exit the menu without selecting a new vessel It is impossible to select a new examination if the acquisition is frozen 13 4 Probe configuration 13 4 1 Introduction For each probe or sensor a configuration menu of the indices is available This probe configuration menu allows to attach different indices to each probe or sensor that can be used for distinct applications 13 4 2 Display and printing configuration Press the QuickButton from the acquisition screen to display the configuration panel Turn the QuickButton to select Probe configuration Press the QuickButton to validate This menu depends on the selected examination as indicated in the hereafter table Dop 4 Dop
4. The sweep speed is the speed at which the curve moves across the screen The time scale expressed in s division or in s cm one division on the paper printout is equal to 1 cm is equivalent to the number of seconds per division The time scale is displayed above the sweep key 4 1 5 Examination The name of the selected examination type is displayed on the screen above the Probe key ee The following data can be displayed e Dop 4M 4 MHz Doppler Dop 8 M 8 MHz Doppler PPG Ph2 Two channel Photo Plethysmography PVR Pn1 Pulse Volume Recording one channel Pneumo Plethysmography PPG Ph1 One channel Photo Plethysmography V R T Venous Reflux Test 4 1 6 Filter The name of the selected filter is displayed on the screen above the Filter key The following data can be displayed e In Doppler mode Artery 1 Artery 2 Vein Average e In Plethysmography PPG ph2 PPG pn1 PPG ph Artery this filter is selected for arterial examination Vein this filter is selected for venous examination 4 1 7 Flow direction In Doppler mode only the sign or is displayed on the screen above the Sign key By convention the velocity is positive if the blood flows towards the probe and the velocity is negative if the blood flows away from the probe 4 1 8 Printer operating mode The name of the selected printer operating mode is displayed above the Operating mode
5. Side indication 4 1 14 Name 4 2 Adjustments and controls DOPPLER EXAMINATION 5 1 Start of the acquisition 5 2 Adjustment 5 3 Acquisition quality 5 4 Validation 5 5 Printing 5 6 Taking systolic pressures in the Doppler mode 5 6 1 Detailed procedure 5 6 2 Printout 5 6 3 Segmental pressure 5 6 4 Limitations of the pressure measurement with Doppler 5 7 Venous Doppler exam TWO CHANNEL ARTERIAL PHOTO PLETHYSMOGRAPHY PPG PH2 6 1 Start of the acquisition 6 2 Adjustment 6 3 Acquisition quality 6 4 Validation 6 5 Printing ONE CHANNEL PHOTO PLETHYSMOGRAPHY PPG PH1 7 1 Start of the acquisition 7 2 Adjustment 7 3 Acquisition quality 7 4 Validation 7 5 Printing 7 6 Taking systolic pressure in the one channel photo plethysmography mode 7 6 1 Performing the pressure measurement in the one channel photo plethysmography mode 7 6 2 Printout 7 7 Limitation of the pressure measurement with PPG ONE CHANNEL PNEUMO PLETHYSMOGRAPHY PULSE VOLUME RECORDING 8 1 Start of the acquisition 8 2 Adjustment 8 3 Acquisition quality 8 4 Validation 8 5 Printing 01274H 34 34 36 36 36 37 38 38 39 39 39 40 40 40 43 44 45 45 46 46 46 47 Ans m dical USER S MANUAL BASIC 9 VENOUS REFLUX TEST 9 1 Start of the acquisition 9 2 Printing 9 3 Adjustment 9 4 Examination with a tourniquet 9 5 Limitations of the V R T 10 ABI TEST WITH PHOTOPLETHYSMOGRAPHY 10
6. 1 Right brachial systolic pressure 10 2 Left brachial systolic pressure 10 3 Right ankle systolic pressure 10 4 Left ankle systolic pressure 11 ABI TEST WITH DOPPLER 11 1 Right brachial systolic pressure 11 2 Left brachial systolic pressure 11 3 Right ankle systolic pressure 11 4 Left ankle systolic pressure 12 EXAMINATION STORAGE IN THE BASIC 12 1 Description 12 2 Image storage 12 2 1 Configuration menu when no archive is open 12 2 2 Configuration menu when an archive is open 12 3 Processing of the stored images 12 3 1 Listing 12 3 2 Archive processing menu 12 4 Storage capacity 12 4 1 Archive full 12 5 Storage memory full 13 CONFIGURATION 13 1 Side 13 2 Select vessel 13 3 Examination 13 4 Probe configuration 13 4 1 Introduction 13 4 2 Display and printing configuration 13 4 3 Index configuration 13 4 4 Index list 13 5 Date and time 13 6 Unit configuration 13 7 New archive 01274H 48 48 51 51 52 52 53 53 54 55 56 57 37 58 59 60 61 61 61 61 62 62 62 63 64 64 64 65 A tys m dical USER S MANUAL 14 15 16 17 18 20 21 01 274H BASIC 13 6 Close archive 13 9 Archive X archives Y images SPECIFICATIONS 14 1 Continuous Doppler 14 2 Pressure transducer 14 3 Printing 14 4 Sound 14 5 Control 14 6 Display 14 7 Environmental characteristics 14 8 Electrical characteristics 14 9 Mechanica
7. Do not leave the unit on line with the Doppler probes on the patient if it is not necessary for the appropriate diagnostic procedure 1 5 Customer responsibility The BASIC performs properly only when operated and maintained as specified in this manual and the BASIC service manual It is the responsibility of the customer to use the BASIC in accordance with the instruction manual the warnings and the labels If the product is found defective it should not be used The system should not be used if any parts are missing or are damaged Parts that are visibly broken worn out warped or contaminated must be replaced immediately with new parts supplied by ATYS No components should be replaced with parts from any other manufacturer If the customer suspects a part may be defective it is the customer s responsibility to contact ATYS 1 6 Patients and examiners safety To prevent electrical shock hazards do not remove cover For service contact a qualified service representative Switch off the power to the system before attempting any service or maintenance activity related to cabling or connections Have a service engineer check the integrity of the system ground and leakage current every year To prevent fire and electrical hazards keep the BASIC out of rain water and humidity If the system does come in contact with water or any liquid shut the system down and disconnect the system from the power cable and contact your ATYS service rep
8. Immediate mode IMDT is advised Selection of the vessel name turning the QuickButton or with the Select vessel menu 8 3 Acquisition quality The acquisition quality can be judged according to the following criteria e The number and the location one per cycle of the systole markers have to be correct e The displayed heart rate is a good indicator easy to check It must be steady the discrepancies between to successive cycles must not be greater than 10 and coherent with the patient heart rate If no systole markers are displayed and if the indices are not calculated it may be due to the selected amplitude Try to decrease the value of the scale of the y axis with the Amplitude key So the height of the displayed signal will be higher The Y axis scale must be chosen to take advantage of the full screen Nevertheless the waveform must not go out of the screen otherwise the calculations are not correct 8 4 Validation Display freezing When the display offers a satisfying quality the screen can be frozen by pressing Pedal Once the acquisition is frozen the curve is drawn again Markers point out the location of systoles The displayed index calculations concern the last proper cycle for which the systole markers are displayed 01 274 H 46 A tys m dical USER S MANUAL BASIC Scrolling The BASIC automatically saves the most recent one minute of a waveform Scrolling lets you view a waveform tha
9. MANUAL BASIC Obtain a good quality waveform e Press Null to enter the pressure measurement mode The following message is displayed Adjust Cuff Pres NEXT PED It means that you can adjust the cuff pressure The next step is to press Pedal to inflate the cuff The default value of the cuff pressure is 60 mmHg It cannot be greater than 110 mmHg e f necessary change the cuff pressure turning the QuickButton e Press the foot pedal to inflate the cuff to the set pressure The user has to press the foot pedal all along the inflation Otherwise the inflation is stopped The volume changes are recorded e Press Pedal to stop the recording deflate the cuff and freeze the screen e Press Nul to return to the acquisition screen without printing Pedal to print the pressure At any time during the examination press e Null to deflate the cuff The displayed window allows you to change the value of the set pressure and to resume the examination Press Null again to leave this window e Pedal to freeze the acquisition window and deflate the cuff 8 2 Adjustment During the acquisition the user performs the following adjustments Selection of the artery mode with the Filter key The artery filter must be selected Amplitude adjustment Sweep speed adjustment The advised sweep speed is 0 4s cm Zero line adjustment Selection of the printer operating mode The
10. Unit configuration with the QuickButton Press the QuickButton to validate Select pump slow speed turning the QuickButton and press the QuickButton Adjust the pump speed with the QuickButton The default value is 2 Press the QuickButton to validate Press the Null key or select Exit and press the QuickButton to leave the unit configuration panel 13 7 New archive See section 12 13 8 Close archive See section 12 13 9 Archive Xarchives Y images See section 12 01 274 H 69 A tys m dical USER S MANUAL BASIC 14 SPECIFICATIONS 14 1 Continuous Doppler True bi directional Doppler for the sound and directional Doppler for the display Frequencies 4 MHz or 8 MHz Ultrasonic power lt 50 mW cm Filters Artery 1 Artery 2 Vein and Average Sign selection Zero line location three locations available 14 2 Pressure transducer Accuracy 0 300 mmHg 3 mmHg or 2 of reading whichever is greater 40 bpm lt heart rate lt 180 bpm 14 3 Printing Paper width 60 mm Resolution 200 DPI 8 dots per mm Printing speed up to 25 mm s Paper roll length 25 m 14 4 Sound Sound stereo amplifier 2x 40 W RMS Volume control on the front side Headphone socket by Jack 3 5 mm 14 5 Control Membrane key board with 9 keys QuickButton Foot switch pedal for the printing control single or dual in option 14 6 Display Backlighted liquid crystal display 120 mm 64 mm Re
11. a pressure cuff on the patient s thigh The pressure cuff acts as a tourniquet that excludes the effect of the superficial system to allow testing of the deep system To perform the Venous Reflux Test prepare the patient e Attach an adhesive pad to the sensor side of each disk Remember to use an adhesive pad only once since it may lose some of its adhesion when moving from site to site and then not stick to the skin throughout the test e Attach the PPG probe to the skin within the distance range distal to the ankle bone see figure This distance is indicated by a mark on the sensor cable Align the cord with the ankle bone and attach the venous photo plethysmography sensor to the leg It is recommended that the probe be attached so that the cord hangs down the leg toward the ankle thus reducing the chance of it pulling away from the skin Have the patient sit on a chair or padded table with his her feet flat on the floor Make sure there is no constriction under the patient s legs You may have to shave the body hair before adhering the probes to the skin surface The ideal probe position varies from patient to patient If you do not get a good waveform reposition the probe closer to the ankle 01 274 H 48 A tys m dical 01274H USER S MANUAL BASIC Adhesive pad Sensor with an adhesive pad 49 A tys m dical USER S MANUAL BASIC During the examination messages are displayed on the lower p
12. blood velocity is displayed above the zero line Zero line Press this key to adjust the zero line location This key allows to move the zero line from the first division that corresponds to the lower edge of the frame up to the third division 01 274 H 19 A tys m dical USER S MANUAL BASIC there are three possible locations of the zero line This adjustment of the zero line allows to take advantage completely of the amplitude of the signal 01 274 H 20 A tys m dical USER S MANUAL BASIC Printer operating mode Press this key to select the continuous immediate or automatic mode This key allows to switch from one mode to the other The selected operating mode is indicated on the display with the following symbols e Continuous CONT e Immediate IMDT e Automatic AUTO In continuous mode the BASIC operates as a conventional paper recorder One push on the Pedal key allows to start the recorder a second push allows to write on the paper the adjustment parameters and to stop the paper recorder A In immediate mode a push on the Pedal key allows to freeze the display If the frozen curve is not satisfying a push on the Null key allows to resume the examination without printing A second push on the Pedal key allows to print the frozen curve Once the printing is over the display is unfrozen and the examination can be resumed The automatic mode is similar
13. is drawn again Markers point out the location of systoles and diastoles e The displayed index calculations concern the last proper cycle for which the systole and diastole markers are displayed e Itis still possible to change the vessel name with the Select vessel menu press the QuickButton to reach this menu Scrolling The BASIC automatically saves the most recent one minute of a waveform Scrolling lets you view a waveform that is no longer on the screen Since the instrument prints only the data shown on the screen you may scroll to view the waveform you want to print The different calculations and parameters are then updated Once the acquisition is frozen turn the QuickButton counter clockwise to review the previous waveform It is also possible to change the sweep speed sign filter and zero line position 5 5 Printing 28 02 00 14n54mn07s DOP 4M Filter Artery 1 D 10 mm Scale 1KHz 40cm s Speed 0 4s cm Ss DiaS ons _118lens 26 Once the acquisition is frozen the screen can be printed out by pressing Pedal e Inthe immediate printer operating mode the system returns automatically to the acquisition mode after the printout e Inthe automatic printer operating mode the system does not return to the acquisition mode after the printout it remains frozen This allows several printouts after scrolling Press Null to unfreeze the acquisition If th
14. its own 7 1 Start of the acquisition Place or tape the sensor on the desired location To perform the examination connect the arterial sensor to the left hand side connector on the BASIC A 4 Position the patient appropriately on his her back on the examining table You may elevate the patients head with pillows for greater comfort The patient s hands should be resting comfortably on the examining table For accurate exam results the patient must be warm The room temperature should be between 22 C and 25 C The patient must remain relaxed throughout the exam Remind the patient to remain still and to refrain from talking Vasoconstricting and vasodilation agents may affect PPG signals Use of cigarettes coffee vasoactive drugs or an abnormal room temperature should be noted when performing PPG exams 01 274 H 38 Atys m dical USER S MANUAL BASIC Select PPG ph1 in the examination menu e From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on PPG ph1 Press the QuickButton The BASIC returns automatically to the acquisition screen Select the vessel name with the QuickButton Obtain a good quality waveform 7 2 Adjustment During the acquisition the user performs the following adjustments Selection of the
15. key The following data can be displayed see 3 5 e AUTO Automatic mode e IMDT Immediate mode e CONT Continuous mode 4 1 9 Message A message can be displayed on the bottom or the right hand corner of screen This message let you know what must be done 4 1 10 Indices The device displays the real time value of up to four indices The indices are displayed on the upper left hand corner of the screen Composition Each index is composed by e four characters name e four characters unit e value 01 274 H 24 A tys m dical USER S MANUAL BASIC Calculation The indices are calculated e Inreal time every second e in delayed time during the scrolling on the last cycle visible on the screen The value of the index is displayed only if it is correct When it is not correct the value is replaced by If the waveform is truncated the indices are likely to be underestimated If the waveform is too small with regards to the whole display the indices are likely not to be calculated Choice The index type is chosen by the user among a listing with the configuration menu The indices are selected for each probe or sensor The available indices are presented in 13 4 3 CONFIGURATION section Index configuration 4 1 11 Clock The clock indicates the present time This value can be modified by the user with the configuration menu The time is stored thanks to a battery 4 1 12 Ci
16. pressure measurement Comment Unless there are extenuating circumstances the brachial pressures should be within 20 mmHg of each other If the pressure difference is greater than 20 mmHg retesting is recommended 11 3 Right ankle systolic pressure After this measurement the right ABI RPI will be calculated Secure a cuff around the patient s right ankle Use the 8 MHz probe e Turn the QuickButton to select the proper vessel name You will not find Ankle you can select for example posterior tibial or dorsalis pedis e Press twice the QuickButton to display right e Press Pedal e Position the Doppler probe over the posterior tibial or dorsalis pedis artery Obtain a good Doppler signal e Input the occlusion pressure turning the QuickButton The 100 mmHg default value could be convenient If you keep the default value you start to inflate the cuff up to 100 mmHg and then you resume the inflating up to the real occlusion pressure by releasing and pressing again the foot pedal Release the foot pedal when the occlusion is performed the Doppler signal has disappeared e Press Pedal You must press the foot pedal all along the inflating e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen
17. pressures at different locations You can perform a general Doppler procedure a Doppler venous exam and take systolic pressure The functions of the transducers are reported in the table below 8 MHz CW Transducer 4 MHz CW Transducer Digital Artery Evaluation Extracranial Carotid Evaluation Vessels closer to the skin surface Vessels deeper in the body Smaller patients Larger patients Venous evaluation e Photo plethysmography mode PPG used to evaluate capillary blood flow in tissues You can used PPG in the arterial or venous mode The arterial mode is used to assess the arterial blood supply to a specific location You can also record systolic blood pressure in the extremities while using the PPG arterial mode The venous mode is used to assess valvular insufficiency by performing a Venous Reflux Test e Pneumo plethysmography mode used to record changes in blood volume in the arms legs fingers and toes You can perform an exam in the pneumo plethysmography arterial mode The arterial mode allows to assess arterial blood supply to a specific location on a patient s body Comment a Doppler probe or an arterial photoplethysmography sensor and a pressure cuff are required to perform systolic pressure examination A pressure cuff is placed on the leg arm or digit under examination The Doppler probe or the arterial photoplethysmography sensor is used to locate an artery distal to the cuff The cuff is inflated to st
18. s div The sweep velocity is adjustable as 5 s div 1 6 s div 0 8 s div 0 4 s div 1 div 1 division 1cm on the paper and 0 94 cm on the screen 16 2 Photo sensors The arterial photo sensors are non focused sensors with two emitters and a centre receiver Emission power is 13 mW typ Emission intensity is from 1 7 mW sr to 3 4 mW sr 3 units The venous photo sensors are non focused sensors with four emitters and a centre receiver Emission power is 13 mW typ Emission intensity is from 1 7 mW sr to 3 4 mW sr 3 units Receiver polarisation is adjusted for each unit to ensure the dynamic range S N ratio is limited to the numeric conversion noise 42 dB The total dynamic range is available using the on board adjustable gain 16 3 Pneumo module The pressure sensor is used to measure pressure level relative to atmospheric pressure level Available range is from 0 to 300 mmHg Sensor interface is adjusted in offset at 5 mbar and in 01 274 H 73 Atys m dical USER S MANUAL BASIC value at 5 The sensor is soldered on the measurement main board so the board is calibrated for each production unit S N ratio is limited to the numeric conversion noise 42 dB The total dynamic range is available using the on board adjustable gain 01 274 H 74 A tys m dical USER S MANUAL BASIC 17 CLEANING DISINFECTION AND STERILISATION OF ATYS EQUIPMENT The BASIC is not intended to be used on no intact skin It is a non critical p
19. superficial and deep venous systems in both legs In a normal patient competent valves in the venous system of the legs prevent reflux of the blood backflow of the blood in the veins In this test photo plethysmography is used to measure changes in the capillary blood flow The photo plethysmography probe records instantaneous changes in the blood content of the skin that occur when there are changes in the venous pressure The printed results include the venous reflux waveforms and an indication of the interval of time required to refill the venous system These results allow the physician to determine whether to perform further evaluation of the patient s venous system 9 1 Start of the acquisition For accurate exam results the patient must be warm The room temperature should be between 22 C and 25 C The patient must also rest quietly for two minutes before you begin the test If necessary dim the lights while the patient rests For accurate test results remind the patient to sit still and to refrain from talking throughout the Venous Reflux Test It is very important for the patient to rest without talking or moving his her legs for a full two minutes before performing the calf exercises First perform the Venous Reflux Test without placing a tourniquet on the patient This test allows you to evaluate the patient s superficial and deep venous systems If the test results are abnormal repeat the test after placing
20. the Pedal key For the double switch pedal e The left switch is equivalent to the Pedal key e The right switch is equivalent to the Null key Plugging The foot switch if needed must be connected to the DIN socket located on the rear panel The single foot switch can be placed in its transportation case next to the power cable where it can remain connected to the BASIC 3 9 Headphones To connect your headphones the following operations are to be performed otherwise you may damage your headphones and BASIC CAUTION Use only stereo earphones other earphones may damage the BASIC Switch off the BASIC Cut off the sound from the loudspeakers turn the volume control button fully counter clockwise Connect your headphones on the front panel Switch on the BASIC 3 10 Transportation For transport e Put the Doppler probes in their case Remove the infrared sensor and the cuff Take out the lateral handle Check that the cover of the paper roll case is well locked and put the BASIC on its lateral feet Put the foot pedal and the power cord in the rear case For the transport the foot pedal and the power cord can remain connected to the BASIC 01 274 H 22 A tys m dical USER S MANUAL BASIC 4 OPERATION 4 1 Objects on the acquisition screen The following screen represents the acquisition screen Real time value of four Scrolling AD mere Name and side of the vessel indices indicator DO
21. the manufacturer of the low level disinfecting agents The use of a liquid low level disinfecting agent is recommended for example ethanol iso alcohol Note No components are supplied sterile to the user 17 3 Cuffs Never place the cuffs over open wounds or allow them to come in contact with body fluid Use only hospital approved cleaning agents FDA cleared to clean the cuff after each use and wipe dry immediately see the labeling from the cuff manufacture 17 4 Console e Always turn off the system and disconnect it from the power outlet before cleaning the machine Otherwise electric chock may result e Do not place fluid on or near the system e Clean the external surface casing with soft cloth soaked with alcohol e Make sure that the cloth is damp but not saturated as you should avoid introducing fluids into areas of electrical components e The glass surfaces screens LCD must be carefully cleaned in order to prevent to scratch them Use optical lens cleaners to clean the glass surface e Allow the unit to dry before returning it to operation 17 5 Screen The screen is protected by synthetic pane against knocks Yet cautions must be adopted at the cleaning of the pane not to damage it Cleaning with optical lens cleaners Caution the screen must not be exposed at the sun or heat 17 6 After sales service To obtain additional information contact your ATYS representative 18 PACKING THE BASIC FO
22. through the lower opening of the printing head the upper opening is dedicated to the output of the paper The paper roll is placed in its case so that the paper can go out horizontally towards the insertion slot The direction of the paper enrolling must be respected to place the thermal sensitive side properly that is downwards at the insertion visible when ejected Put down the lever 01 274 H 21 A tys m dical USER S MANUAL BASIC At the end of printing the paper is ejected in order to place the line to cut in front of the cutter At the start of printing the paper is swallowed again in order to begin the printing on the edge of the paper In this way the printings follow one another with no blank between them 3 7 Sound Doppler only A button on the front side controls the sound volume The balance and the tonality adjustments are operated in factory The loudspeakers are on the lateral sides of the BASIC Note 1 be cautious not to introduce any object or liquid into the sound outputs at the risk of damaging the equipment Note 2 to obtain a proper sound quality be cautious not to obstruct these outputs 3 8 Foot switch At the delivery the single foot switch is put in the rear case A single or double option foot switch allows remote control The function of the foot switch is also available on the control keyboard The equipment then can be used without foot switch The single foot switch is equivalent to
23. to listen carefully as the auditory sounds cab offer valuable insight into the vascular condition Probe position and technique are important in obtaining quality waveforms 5 7 Venous Doppler exam Use the Doppler venous exam to screen patients with suspected valvular incompetency deep vein thrombosis or superficial thrombophlebistis A Doppler venous exam compares blood flow in a leg with the blood flow when the leg is compressed both distally and proximally to the probe location When you compress the leg distal to the probe you force the blood to move faster toward the probe This faster movement of the blood causes an augmented Doppler sound unless there is an obstruction in the blood vessel When you compress the leg proximal to the probe you restrict the blood flow to the heart This compression allows you to test the valves on the proximal side If the valves are competent you should hear no Doppler sound Use the 4 MHz probe for this test You may have to explore the following sites e Common femoral vein Superficial femoral vein Popliteal vein Posterior tibial vein ankle Greater saphenous vein 01 274 H 33 A tys m dical USER S MANUAL BASIC 6 TWO CHANNEL ARTERIAL PHOTO PLETHYSMOGRAPHY PPG PH2 Use this examination to evaluate capillary blood flow in the tissues You can use PPG ph2 in the arterial mode to assess the arterial blood flow supply to specific location The venous mode is used to assess va
24. to the immediate mode but once the printing is over the display remains frozen To resume the examination press the Null key Pedal This key is equivalent to the foot pedal e This key allows to freeze the acquisition e This key allows to print the display e This key has a validation function during specific examinations Null This key is equivalent to the right switch of the double switch foot pedal the double switch foot pedal is an option This key allows to exit menus This key has also a START EXIT function during specific examination e Venous reflux test e Pressure measurement e Pulse volume recording inflate the measure cuff e Reset to zero in photo plethysmography venous mode When the curve is frozen press this key to resume the examination without having to print the frozen curve 3 6 Paper and printing 3 6 1 Local printing Paper type The printing paper is thermal paper especially designed for ATYS to obtain the best result and the longest life of the printer It is not compatible with the types of thermal paper used with fax for instance the point of temperature is higher Unexpected stop of printing In case of lack of paper or if the paper insertion lever is up the printing stops till the correction of the mistake A red line on the paper indicates the near end of the paper Changing the paper Open the cover of the paper case and raise the lever to free the printing head Enter the paper
25. units before the tens and vice versa For example to change the time from 24 h to 15 h first change 2 in 1 then 4 in 5 25 his nota correct time To change the day number from 29 to 30 change first 9 in O then 2 in 3 39 is nota correct day number Press the QuickButton to validate Press the Null key or select Exit and press the QuickButton to leave the date and time configuration panel 13 6 Unit configuration Hardware Exit LANGAGE English defaul defaul defaul defaul probe 4MHz probe 8MHz probe Arterial Photo t t t t probe Arterial Pneumo default probe Venous Photo print curve on pressure pump slow speed time to deflate Basic 2 20a Doppler 2 00 Printer 1 10 The unit configuration allows to choose the language to adjust the pump speed to input the deflating delay and to initialise each probe or sensor parameters to the default values 01 274 H 68 A tys m dical USER S MANUAL BASIC To change language the following operations are to be performed From the acquisition screen press the QuickButton The configuration panel is then available Select the Unit configuration with the QuickButton Press the QuickButton to validate Select language turning the QuickButton and press the QuickButton to validate Adjust the language turning the QuickButton Press the QuickButton to validate Press the Null key or select Exit and press the QuickBut
26. 6 Understanding the digital test The digital test is used to evaluate and characterise the arterial blood flow in hands and feet This exam can use e Doppler recording e PPG waveforms recording e Systolic pressure measurement e Pulse volume measurement Examine the waveforms see 21 1 21 221 2 21 3 Rounded and low height waveforms may indicate a possible obstruction You can also examine the RPI indices in the finger and toe RPI for finger Finger systolic pressure Highest brachial pressure RPI for toe Toe systolic pressure Highest brachial pressure You can use the following diagnostic guideline for interpreting the indices based on Rutherford s Vascular Surgery Condition RPI Normal RPI for finger 0 75 or higher Normal RPI for toe 0 75 or higher 01 274 H 82 A tys m dical USER S MANUAL BASIC 21 7 Understanding the Venous Reflux Test V R T You can use the following guideline to interpret the results of the V R T V R T without tourniquet Normal Refill time is greater than or equal to 20 s indicating that the valves appear to be competent and that the arterial system begins to refill the venous system as the blood is forced out of the leg Abnormal Refill time is less than 20 s indicating that the valves may be incompetent and the blood pumped out during reflux is allowed to flow backwards during the resting phase V R T with tourniquet Normal The deep
27. 8 PPG ph1 and ph2 PVR Pn1 4 MHz 8 MHz Photol Pneum Exit Exit Exit Exit Diameter 10 mm Diameter 10 mm Diameter not used Diameter not used Angle 60dg Angle 60dg Angle not used Angle not used INDEX INDICES INDEX INDICES INDEX INDICES INDEX INDICES Nr Labl unit Nr Labl unit Nr Labl unit Nr Labl unit 15H R BPM 1 15H R BP 1 15H R BPM 1 15H R BPM 2 1SSys cm s 2 1SSys cm s 2 12P1sL 2 12P1sL 3 7Aver cm s 3 7Aver cm s 3 13PISR 3 0 4 0 4 0 4 0 There is no configuration menu for the V R T 01 274 H 66 Atys m dical USER S MANUAL BASIC 13 4 3 Index configuration Up to four indices can be displayed in real time These indices are selected in the probe configuration menu Each index comprises a name and a unit The following operations have to be done in order to change the index configuration of a probe or a sensor e Press the QuickButton from the acquisition program to display the configuration panel e Turning the QuickButton select the probe configuration e Press the QuickButton to validate e The four indices are reported in the bottom of the panel Turning the QuickButton to select with the cursor the index to be changed press the QuickButton to validate e Use the QuickButton to change the number of the selected index e The name and the unit corresponding to the index number are displayed e Press the QuickButton to valida
28. BASIC 8 USER S MANUAL 01 274 H A tys m dical USER S MANUAL BASIC This document contains information on the BASIC manufactured by ATYS Sarl Information in this document is subject to change without notice and does not represent a commitment on the part of ATYS Sarl ATYS Sarl does not assume liability for damages that may occur as a result of the use of the information in this manual No part of this manual may be reproduced or transmitted in any form for any purpose other than the use of the purchaser of BASIC system 01 274 Rev H Reference BASIC USER S MANUAL July 15th 2005 AtyS M dical 17 Parc d activit s d Arbora 69510 SOUCIEU EN JARREST FRANCE tel 33 4 78 05 69 69 fax 33 4 78 05 69 60 01 274 H 2 A tys m dical USER S MANUAL BASIC CAUTION In USA Federal law restricts this device to use by or on the order of a physician CAUTION The BASIC is not intended for fetal monitoring or fetal use CAUTION The air plethysmography and the systolic pressure measurement modules of the BASIC are not intended for neonatal applications CAUTION The BASIC is not intended for ophthalmic application CAUTION The BASIC or a probe must not be used if damaged CAUTION The BASIC must not be used out of the specified environment CAUTION The operator should limit the length of the Doppler tests to the time required for diagnostic purposes to min
29. ER S MANUAL BASIC 10 ABI TEST WITH PHOTOPLETHYSMOGRAPHY This test allows to screen a patient for arterial disease in the lower extremities This exam uses e A photoplethysmography sensor to sense the patient s blood flow e A pressure cuff to measure the systolic pressure This test determines the Ankle Brachial Index In the BASIC ABI is label RPI Residual Pressure Index ABI Ankle systolic pressure Highest brachial pressure The following measurements are to be performed successively e Right brachial systolic pressure e Left brachial systolic pressure e Right ankle systolic pressure e Left ankle systolic pressure The RPI Residual Pressure Index is more general than the ABI RPI systolic pressure of any location Highest brachial pressure For RPI test you can follow the ABI procedure but the location of the cuff is different 10 1 Right brachial systolic pressure Secure a cuff around the patient s right arm Tape an infrared arterial sensor on a patient s right digit The procedure is the same as described in 7 6 If not already done select PPG ph 1 examination from examination selection menu e From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on PPG ph 1 Press the QuickButton The BASIC returns au
30. P 48 Artery 1 E AUTO 4g cm Horizontal scale X axis Examination Filter Flow Printer operating mode name direction 4 1 1 Curve This object represents the analysis of the signal from the probe or the sensor The curve is modified during the signal acquisition with a frequency of 200 times per second The curve is drawn from the signal processing It represents the instantaneous values used to calculate the indices 4 1 2 Grid A grid is displayed it allows an estimation of the values of the points of the curve and time The units of the grid are reported on the screen 4 1 3 Vertical unit 4 1 3 1 Doppler The blood flow velocity is expressed e in Hz which indicates directly the frequency deduced from the analysis e incm s taking into account a constant angle between the probe and the blood flow The scale unit used in Doppler physics is Hz However the user frequently needs to know the velocity value as a clinical measure The measure in Hz is more precise but depends on the probe frequency The velocity scale is displayed beside the Amplitude key 4 1 3 2 Photo plethysmography The gain is displayed beside the Amplitude key 4 1 3 3 Pneumo plethysmography The scale is expressed in mmHg division It is displayed beside the Amplitude key 01 274 H 23 Atys m dical USER S MANUAL BASIC 4 1 4 Horizontal unit Time scale The time scale depends on the sweep speed or paper unrolling speed
31. QuickButton to select the proper vessel name You will not find Ankle you can select for example Tibial e Press twice the QuickButton to display right e Press Pedal e Input the occlusion pressure turning the QuickButton The 100 mmHg default value could be convenient If you keep the default value you start to inflate the cuff up to 100 mmHg and then you resume the inflating up to the real occlusion pressure by releasing and pressing again the foot pedal Release the foot pedal when the occlusion is performed the photoplethysmography signal has disappeared e Press Pedal You must press the foot pedal all along the inflating e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure and ABI RPI value are displayed on the upper left hand side corner beside the label Pres The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on an other location of the cursor 01 274 H 55 A tys m dical USER S MANUAL BASIC e Press Null to return to the acquisition screen without printing Pedal to print the ankle pressure The BASIC is ready for another pre
32. R SHIPPING ATYS ships the system in a box specially designed for the BASIC This box is made in wood and cardboard This box includes foam guards for protecting the system It is essential to ship the equipment using the original packing materials CAUTION if you do not have the original packing materials contact your ATYS dealer 19 WASTING OF THE PACKAGE AND OF THE BASIC The package and the BASIC do not contain any dangerous components The wasting of the package and the BASIC must be performed according the national regulations CAUTION Before wasting the BASIC it is necessary to remove the lithium button battery The lithium battery is located on the main board BPMIC The lower cover must be removed to reach the BPMIC board See the service manual for information about how to remove this cover 01 274 H 76 A tys m dical USER S MANUAL 20 BASIC CHARACTERISTICS OF THE PRESSURE CUFFS The characteristics of the cuffs are reported hereafter The cuffs include a cover a bladder a pipe and velcro or hook The cuffs must be pressure cuffs They are standard cuffs for vascular studies The size of the cuffs must be well adjusted to the size if the limb or digit under study arm thigh or digit The maximum internal pressure in the cuffs is 320 mmHg The cuffs must be able to withstand this pressure The cuffs are one tube model The cuffs are washable The cuffs are Velcro or hook cuff It is advised to use
33. The amplitude must be well adjusted in order to get accurate results e The waveform must not be truncated e The waveform must not be too small with regards to the available space on the screen The waveform must take full advantage of the available space Filter e In Doppler mode Press this key to select the filter This key allows to select successively the filters Artery 1 Artery 2 Vein and Average and then to return to Artery 1 The selected value is written on the display as Artery 1 Artery 2 Vein and Average respectively This filter allows to smooth the waveforms e In plethysmography mode Press this key to select the examination type arterial or venous The selected value is written on the display as Artery or Vein Sweep Press this key to select the sweep speed This key allows to select successively the speeds 5 1 6 0 8 0 4 then to return to the value 5 These values are indicated in s cm or s div Flow direction This key is used only in Doppler mode This key is the flow direction key press this key to switch from to or from to indicates that the blood flow displayed above the zero line runs toward the probe indicates that the blood flow displayed above the zero line runs away from the probe Normally the flow towards the probe is displayed above the zero line and the flow away from the probe is displayed below the zero line CAUTION The indices are properly calculated only if the
34. Vess Name NEXT PED You can still adjust the vessel name turning or pressing the QuickButton 01 274 H 57 A tys m dical USER S MANUAL BASIC e Press Pedal to validate the name of the vessel and go to the next step The following message is displayed Occlusion PRESS NEXT PED It means that you can now adjust the value of the cuff pressure that is supposed to be equal to the occlusion pressure The next step is to press pedal to inflate the cuff The default value of the occlusion pressure is 100 mmHg It is displayed in the upper left hand corner beside the label Occl It can be adjusted turning the QuickButton The occlusion value cannot be greater than 300 mmHg e Press the foot pedal to inflate the cuff Beeps must be heard before starting the pressure measurement For safety the user has to press the foot pedal all along the inflation Otherwise the inflation is stopped During the inflation the following message is displayed Inflating PED The BASIC inflates the cuff up to the input occlusion pressure and then deflates the cuff automatically The deflating occurs X seconds deflation delay after the end of the inflating So during this time if the input occlusion pressure is not high enough it is possible to resume the inflating without deflating the cuff To do so release the Pedal and just after press again the Pedal the inflating is resumed You can release the Pedal as soo
35. ange from the normal to the severely obstructed vessel The illustrations show the steady deterioration of waveform features as the obstruction progresses dicrotic notch 1 l _ P Ll i eee PPG waveform for a normal vessel Note the steeply raising upslope and sharp peak during systole and distinct dicrotic notch indicating period of flow reversal in the artery PPG waveform for a vessel with a mild obstruction Note the less steep upslope and a less distinct peak and loss of the dicrotic notch on the downslope PPG waveform for a vessel with a moderate obstruction Note the low amplitude and marked abnormalities as in moderate obstruction 01 274 H A tys m dical USER S MANUAL BASIC PPG waveform for a vessel with a severe obstruction Note the disappearance of pulsations To test for sympathetic tone e The sweep speed was decreased to 1 6s cm e Have the patient take and hold a deep breath then release it The waveform pattern looks like this for a normal sympathetic response 31 12 02 12h05mn23s PPG ph1 Filter Artery Speed 1 6s cm ea 30 15 f2 00f s 00 21 3 Air pneumoplethysmography Pulse volume recording The following illustration shows a normal waveform PVR pni Digit Arterys Left Filter Artery if 02 03 16h05m Scale 0 02mmHg Speed 0 4s cm R PlsL fu 81 l e
36. archive To display the menu that allows the archive processing put the cursor on the selected archive and press the QuickButton 01274H 62 A tys m dical USER S MANUAL BASIC 12 3 2 Archive processing menu Archive Name Patient 1 Date 04 09 2001 Territory Upper limbs Images 12 View Clear Archive Send Archive to WinAtys Print Full Archive Exit The upper part includes a description of the archive e Name Date and time of the creation of the archive Territory of the examination Number of images in the archive The lower part includes the menu Archive menu View put the cursor on View and press the QuickButton The stored images are displayed chronologically turning the QuickButton Press Pedal to print out the displayed image or to send it to the WinAtys software To leave the archive display press e NUL to go back to the configuration menu e The QuickButton to go back to the archive processing menu Archive menu Clear Archive put the cursor on Clear Archive and press the QuickButton The following message is displayed Clear Archive YES NO Put the cursor on YES or NO and press the QuickButton to validate If the answer is YES all the images of the archive are cleared and consequently lost Archive menu Send Archive to WinAtys put the cursor on Send Archive and press the QuickButton The complete archive is sent through the RS232 connection to the PC
37. art of the screen to let you know what to do Select Venous Reflux Test V R T in the examination selection menu From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on V R T Press the QuickButton The BASIC returns automatically to the acquisition screen You can either press Null to start the examination Enter to go to the configuration menu in order to select another examination and so to leave the V R T Pedal this action freezes the screen press Null to unfreeze it Press Null to start the test The examination starts with a calibration The following message is displayed on the screen 1 calibrating wait The calibration lasts 5 s After the calibration period the signal is displayed during 5 s with the following message 2 lt PEDAL gt to continue It means that you have to press Pedal to go to the next step The signal must be stable to go to the next step If the signal is not stable wait for another calibration Perform as many calibrations as necessary to get a rather stable signal ANT NES gt A Calibration period End of calibration Press Pedal at the end of calibration when the signal is stable The following message is displayed 3 pump whe
38. artery mode with the Filter key Select the Artery filter Amplitude adjustment Sweep speed adjustment The advised sweep speed is 0 4s cm Zero line adjustment Selection of the vessel name Selection of the printer operating mode The Immediate mode IMDT is advised 7 3 Acquisition quality The acquisition quality can be judged according to the following criteria e The number and the location one per cycle of the systole markers have to be correct e The displayed heart rate is a good indicator easy to check It must be steady the discrepancies between to successive cycles must not be greater than 10 and coherent with the patient heart rate 7 4 Validation Display freezing When the display offers a satisfying quality the screen can be frozen by pressing Pedal Once the acquisition is frozen the curve is drawn again Markers point out the location of systoles The displayed index calculations concern the last proper cycle for which the systole markers are displayed If no systole markers are displayed and if the indices are not calculated it may be due to the selected amplitude Try to increase the value of the gain with the Amplitude key So the height of the displayed signal will be higher The Y axis scale must be chosen to take advantage of the full screen Nevertheless the waveform must not go out of the screen otherwise the calculations are not correct Scrolling The BASIC automatically saves th
39. ated Turn the push QuickButton to move the cursor in order to get the value of the pressure on another location of the cursor e Press Null to return to the acquisition screen without printing Pedal to print and save the brachial pressure The saved brachial pressure is the one that is used for the ABI calculation After the printout the BASIC is ready for another pressure measurement See 7 6 2 to select the proper printout option 10 2 Left brachial systolic pressure The left brachial pressure is measured just to compare it with the right one e Secure a cuff around the patient s left arm e Tape an infrared arterial sensor on a patient s left digit Turn the QuickButton to select the proper vessel name brachial Press twice the QuickButton to display left instead of right Press Pedal Input the occlusion pressure turning the QuickButton The 100 mmHg default value could be convenient If you keep the default value you will start to inflate the cuff up to 100 mmHg and then you will resume the inflating up to the real occlusion pressure by releasing and pressing again the foot pedal see 7 6 1 You will release the foot pedal when the occlusion is performed the photoplethysmography signal has disappeared e Press Pedal to start the inflation You must press the foot pedal all along the inflating e As the pressure cuff deflates the BASIC records the returning waveform During the deflatio
40. atient contact device 17 1 Doppler probes This procedure concerns the 4 MHz and 8 MHz continuous pencil probes e Be very careful for the cleaning and disinfection of the probes e The tip of the probes may be damaged by shocks the probes must be handled carefully e Never bend or pull the transducer cable The probe comes in contact with intact skin So the risk of infection is low The probe needs only be cleaned and low level disinfected between patients The use of a liquid low level disinfecting agent is recommended for example ethanol iso alcohol Only FDA cleared cleaning agents must be used The user must refer to the labeling instructions provided by the manufacturer of the cleaning agents Only FDA cleared low level disinfectant agents must be used The user must refer to the labeling instructions provided by the manufacturer of the low level disinfecting agents Note No components are supplied sterile to the user CAUTION DO NOT USE THE FOLLOWING METHODS OF STERILISATION AND DISINFECTION THEY WOULD INDUCE DAMAGES OF THE PROBES STERILISATION DISINFECTION AUTOCLAVE CHLORINE 100 ULTRASOUND GLUTARALDEHYDE AT 100 HYDROGEN PEROXIDE 100 IODINE AT 100 Long accumulation of ultrasound gel on the face of the probe will cause early degeneration and loss of performance Always remove the coupling gel from the probes after each test Inspect probe regularly for visible cracks and leaks I
41. blood pressure cuffs from Welch Allyn or Hokanson The cuffs must be FDA cleared 01 274 H 77 A tys m dical USER S MANUAL BASIC 21 UNDERSTANDING THE EXAMINATION RESULTS 21 1 Arterial Doppler One of the major methods of deriving diagnosis information from the Doppler is through examination of the recorder waveform morphology The four characteristics to be examined are e Pulsatility e Systolic forward flow e Diastolic reverse flow e Diastolic oscillations Right and left side waveform recordings are analysed and compared Waveform morphology may appear as follows The normal peripheral arterial Doppler waveform may exhibit multi phasic pulsatility sharp rapid systolic upstroke A and downstroke B and variable diastolic reverse flow C and oscillations depending on the artery from which the recording was taken ra B 1 12 02 08h54mn49s A k ah DOP 8M i j I Posterior Tibial TT hi L Right R i Filter Artery 1 at Jee ee D ae js 1 Scale 500Hz 10cm s Speed 0 4s cm P ied on a dE 1 ee yr ESS ae i oer i y J ae U TR oo ul OO Normal bidirectional waveform Note the distinct rapid upstroke and c upstroke and downstroke systole rapid flow reversal and i increase in flow velocity due to arterial wall elastic rebound 31 12 02 O9h58mn 11s DOP 8M i Posterior Tibial re i
42. cally stored in the BASIC 01 274 H 61 A tys m dical USER S MANUAL BASIC 12 2 2 Configuration menu when an archive is open Exit Close Archive Archives 4 archives 32 images To close an archive move the cursor on Close Archive and press the QuickButton The BASIC returns automatically to the acquisition screen When the archive is closed it is possible to open a new one for example in the case of an examination that includes more than 16 images 12 3 Processing of the stored images 12 3 1 Listing To display the listing of the archives From the acquisition screen press the QuickButton the configuration menu is displayed New Archive Archives 4 archives 32 images In the configuration menu the information displayed beside Archives indicates the number of archives and the number of stored images Put the cursor on Archives X archives Y images and press the QuickButton to displayed data about these archives If there is no stored archives the following message is displayed No Archive If archives are stored in the BASIC a detailed listing of all the archives is displayed Patient 1 Lower limbs 04 09 2001 15 12 Patient 2 Upper limbs 12 05 2001 9 56 Patient 3 Cervical 23 04 2001 4 36 Patient 4 Miscellaneous 03 09 2001 19 25 Patient 1 Archive name Upper limbs Name of the examination territory 04 09 2001 15 212 Date and time of the creation of the
43. ckButton and turn it in both directions When you turn the QuickButton counterclockwise the cursor moves down in the menu When you turn the QuickButton clockwise the cursor moves up in the menu From the acquisition screen press the QuickButton to display the configuration menu see 13 To select an item from a menu move the cursor on the item and press the QuickButton Once the item is selected and adjusted press again the QuickButton to validate your choice i ain PEDAL NULL 8 C gt Minus Plus i Double switch foot Left Right pedal Down Up Functions of the QuickButton CAUTIOUS in the user s manual the following notation will be used e Press Enter for press the QuickButton validation of the selection e for turn counterclockwise the QuickButton moving down the cursor or changing the value of a field e for turn clockwise the QuickButton moving up the cursor or changing the value of a field In the configuration menus press Enter before and after the modification of a field with and During acquisition and allow to change the vessel name displayed on the screen When the acquisition is frozen and acquisition screen allow to display the buffer or to move a cursor in the 01 274 H 26 A tys m dical USER S MANUAL BASIC 5 DOPPLER EXAMINATION Use the Doppler mode to assess a patient s vascular health With this moda
44. d Once the acquisition is frozen it is still possible to change the vessel name with the Select vessel menu you can reach it pressing the QuickButton Scrolling The BASIC automatically saves the most recent one minute of a waveform Scrolling lets you view a waveform that is no longer on the screen Since the instrument prints only the data shown on the screen you must scroll to view the waveform you want to print The different calculations and parameters are then updated Once the acquisition is frozen you can turn the QuickButton counter clockwise to review the previous waveform It is also possible to change the sweep speed filter zero line position and the Y axis scale 01 274 H 36 A tys m dical USER S MANUAL BASIC 6 5 Printing lt 21 01 00 11h48mni s PPG ph2 Filter Artery Right Left Speed 0 4s cm E esf 18 ba 86 A w a ns ee Once the acquisition is frozen the screen can be printed out by pressing Pedal e Inthe immediate printer operating mode the system returns automatically to the acquisition mode after the printout e Inthe automatic printer operating mode the system does not return to the acquisition mode after the printout it remains frozen This allows several printouts after scrolling Press Null to unfreeze the acquisition If the continuous printer operating mode is selected press the Pedal ke
45. d and external carotid arteries 01 274 H 10 A tys m dical USER S MANUAL BASIC 1 3 Contraindications The BASIC is not intended for e Fetal monitoring or fetal use e Fetal imaging amp others Abdominal intraoperative pediatric small organ neonatal cephalic adult cephalic e Ophthalmic application e Home use The air plethysmography and the systolic pressure measurement modules of the BASIC are not intended for neonatal applications Do not use the probes the sensors and the cuffs on skin surfaces with recent wounds operative cuts Never use a cuff with patient suffering from swollen lymph glands and or lymph edema Always use the correct cuffs for the different sites in order to minimize the patient s inconvenience Use all cleaning and disinfection procedures applicable to your institution 1 4 Precautions and warnings Ultrasonic waves penetrate deep into the biological tissue The effects of ultrasound on living tissue and organisms have yet to be fully researched although many years of use in clinical applications in a wide variety of areas have shown it to be harmless Ultrasound should be employed with care and used only in situations where the results outweight the risks Patients should not be subjected to unnecessarily high doses e In USA federal law restricts this device to use by or on the order of a physician with the operator presence at all times while the patient is connected to the system e
46. e continuous printer operating mode is selected press the Pedal key to print continuously Press again the Pedal to print the adjustment parameters and to stop the printing 01 274 H 29 A tys m dical USER S MANUAL BASIC 5 6 Taking systolic pressures in the Doppler mode You can record systolic blood pressure using the Doppler mode Secure a pressure cuff on the arm thigh calf ankle or digit you are examining Use the Doppler probe to locate an artery distal to the cuff Inflate the cuff to stop blood flow As the pressure cuff deflates the BASIC records the returning waveform The systolic pressure is estimated by the pressure needed in a blood pressure cuff to stop flow The level of measurement is determined by the site of the compressing cuff not the flow detection site It is the intraluminal pressure under the cuff that must be overcome to stop flow The probe detects the return of the blood flow in The probe detects the return of the blood flow in the posterior tibial artery the brachial artery 5 6 1 Detailed procedure If not already done select Doppler examination from examination selection menu e From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on DOP 4M or DOP 8M Press the QuickButto
47. e They are locked by screwing A single push on the cover of the probe case is enough to lock or unlock it Take the probes out of their case and put them on the probe holder Before locking the cover of the probe case check that the cables go out of the case through the holes provided in the cover 3 3 2 Infrared sensors Connect the two infrared sensors in the two connectors located on the front panel In the one channel photo plethysmography exam only the left hand side connector is active In the two channel photo plethysmography exam e The right hand side connector is related to the patient s right side e The left hand side connector is related to the patient s left side 01 274 H 17 A tys m dical USER S MANUAL BASIC 3 3 3 Cuffs Arm ankle cuff Digit cuffs Thigh cuff Pipes to connect the cuffs to the BASIC Adaptor to connect the small cuffs to the pipes 3 4 Screen The contrast of the display is adjusted by means of the knob located below the lower side of the front panel and indicated by this icon B Caution the screen must not be exposed at the sun or heat 01 274H 18 A tys m dical USER S MANUAL 3 5 4 8 BASIC Keyboard Control keyboard and display Probe this key allows to switch from 4 MHz to 8 MHz or from 8 MHz to 4 MHz Amplitude Press this key to adjust the amplitude This key allows to select successively the different values
48. e cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff Once the cuff is deflated the screen is frozen The systolic pressure and the ABI RPI value are displayed on the upper left hand side corner beside the label Pres The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on another location of the cursor Press Null to return to the acquisition screen without printing Pedal to print and save the ankle pressure The BASIC is ready for another pressure measurement See 7 6 2 to select properly the printout option 01 274 H 60 A tys m dical USER S MANUAL BASIC 12 EXAMINATION STORAGE IN THE BASIC 12 1 Description The BASIC storage system allows to store BASIC examination images Doppler plethysmography and pressure measurement These images are stored in archives An archive includes 1 to 16 images The storage capacity is 120 images for at most 16 archives The stored images can be displayed again and printed out either on the integrated thermal printer or in the PC fitted with the WinAtys software and a RS232 connection An archive must be open to allow the storage of images When an archive is open the images are stored inst
49. e measurement The clinical accuracy measurements of the velocity were carried out by APAVE 177 route de Sain Bel 69 811 TASSIN CEDEX FRANCE file N CNH 95 8262 The measurements were carried out with a string phantom SS 2A Instruments MARK 4 Four constant velocities 25 50 100 200 cm s were measured in water at a 60 angle with forward and backward flow for each frequency and for each filter Since the calculation of the velocity is for an insonation angle of 0 the values were corrected using the cosine of the actual angle of measurement The accuracy values are listed in the table below The accuracy is given with regards to the constant speed Frequency Constant speed cm s 25 50 100 200 4 MHz CW lt 5 lt 2 lt 1 lt 2 5 8 MHz CW lt 4 lt 2 lt 1 lt 2 5 As can be seen the accuracy is high over the whole range of velocities 16 1 2 Range of Doppler controls Doppler Phantom Doppler Sensitivity Frequency Min Max Min Min Max Max Max Velocity Velocity frequency velocity frequency displayed displayed cm s cm s Hz at 60 kHz velocity on velocity as cm s the an index waveform cm s cm s 4 MHz 10 100 200 8 6 0 192 240 8 MHz 10 100 200 4 12 0 192 240 The velocity is calculated on the selected frequency The velocity is displayed on the scale The scale is adjustable as 5 cm s div 10 cm s div 20 cm s div and 40 cm
50. e most recent one minute of a waveform Scrolling lets you view a waveform that is no longer on the screen Since the instrument prints only the data shown on the screen you must scroll to view the waveform you want to print The different calculations and parameters are then updated Once the acquisition is frozen you can turn the QuickButton counter clockwise to review the previous waveform It is also possible to change the sweep speed sign filter zero line position and amplitude 01 274 H 39 A tys m dical USER S MANUAL BASIC 7 5 Printing 11h46mn00s1 Filtre Artere Vites 0 4s cm 8 2 a A Gonn EEE SE A Once the acquisition is frozen the screen can be printed out by pressing Pedal e Inthe immediate printer operating mode the system returns automatically to the acquisition mode after the printout e Inthe automatic printer operating mode the system does not return to the acquisition mode after the printout it remains frozen This allows several printouts after scrolling Press Null to unfreeze the acquisition If the continuous printer operating mode is selected press the Pedal key to print continuously Press again the Pedal to print the adjustment parameters and to stop the printing 7 6 Taking systolic pressure in the one channel photo plethysmography mode You can record systolic blood pressure in the limbs and in the extrem
51. e of the pressure on another location e When the acquisition window is frozen it is possible to go to the configuration menu by pressing the QuickButton You may have to go to the configuration menu to change the label of the vessel 01 274 H 31 Atys m dical USER S MANUAL BASIC e Press Nul to return to the acquisition screen without printing Pedal to print the pressure At any time during the examination you can press Null to leave the pressure measurement window and go back to the Doppler acquisition window During the inflation and deflation mode it is possible To leave the pressure measurement window and deflate the cuff by pressing Null To deflate quickly the cuff by pressing Pedal the pressure measurement window remains displayed 5 6 2 Printout As far as the pressure examination is concerned two kinds of printout are available e A printout of the pressure values and of the curves Doppler and pressure e A printout of the pressure values alone The selection of the kind of printout is performed in the Unit configuration menu see 13 6 i RE EPA 3 ay i tae SEE EEE OPEN ar 24 12 02 ae r DOP 4M PR NE ore Brachial RARE Right Caro ee Nes The above printout is obtained with a low sweep speed gt gt gt This key is used to adjust the sweep speed Once the print out is performed the BASIC returns to e the Doppler acquisi
52. ead of printed out Comments e Once the archive is closed it is no longer possible to store a new image in this archive A new archive must be open e It is possible to create an archive whenever during the acquisition or when the display is frozen 12 2 Image storage Two lines of the configuration menu are dedicated to the storage These two lines depend on the status of the storage system whether it is activated or not 12 2 1 Configuration menu when no archive is open Press the QuickButton to display the configuration menu Exit New Archive Archives 4 archives 32 images Configuration menu Archives 4 archives 32 images Indication of the number of stored archives and images Configuration menu New archive Allows to create a new archive Its name is input with the following menu New Archive If you put the cursor on New archive and press QuickButton the New archive menu is displayed New Archive Date 04 09 2001 15 12 24 Name PATIENT 1 The name is input with the QuickButton e Turn the QuickButton to select a character letter or figure e Press the QuickButton to validate the selected character and to go to the next character field Pressing two times the QuickButton validates the name and the BASIC returns automatically to the acquisition screen When an archive is open the print out is no longer performed on the integrated thermal printer or on the PC The images are automati
53. ent is provided Parameters 4 MHz 8 MHz Ispta 3 Max value 167 346 Power mW 14 7 18 3 fo MHz 4 1 8 2 Zsp CM 0 98 0 67 X6Y 6 0 24 020 0 23 0 09 Az cm 0 8 0 6 Ele cm 0 4 0 3 Glossary of terms Ispta 3 Derated spatial peak temporal average intensity mW cm Power ultrasonic power mW fo Centre frequency MHz Zsp Axial distance used to calculate the derated intensity cm XY Respectively the in plane azimutal and out of plane elevational 6 dB dimensions in the x y plane where Z is found cm Az Entrance beam dimensions for the azimutal plane cm Ele Entrance beam dimensions for the elevational plane cm The derated intensity calculations are based on the measured center frequency of the acoustic signal f MHZ and the distance from the transducer under test to the hydrophone d cm using the derating factor e Acoustic measurement uncertainties The uncertainties in the measurements were predominantly systematic in origin The total uncertainties below 20 is given for all the intensities values reported 01 274 H 72 A tys m dical USER S MANUAL BASIC 16 CLINICAL ACCURACY 16 1 Doppler The subject devices allow to measure the Doppler shift and consequently the blood velocity in vessels 4 and 8 MHz transducers allow to measure the real time blood velocity of blood in peripheral arteries and veins 16 1 1 Accuracy of th
54. es Andrew N MS and James S T Yao MD PhD eds Investigation of Vascular Disorders New York Churchill Livingstone 1981 Nicolas Gary G MD FACS and Franklin J Miller Jr MD Clinical Vascular Laboratroy Diagnosis of Deep Venous Thrombosis Annals of Surgery 186 N 2 August 1977 pp 213 215 01 274H SS A A tys m dical USER S MANUAL BASIC Oppenheim Elliott B MD Diagnosis and Treatment of Peripheral Vascular Disease Peripheral Vascular Disease April 1988 pp 73 76 Osmundson P J MD Noninvasive Tests in the Diagnosis of Peripheral Vascular Disease Office Cardiology 3 1980 271 277 Strandness D Eugene Jr MD Noninvasive Vascular Diagnostic Testing Part I The Arterial Examination Physicians Market Place January 1989 pp 1 6 Strandness D Eugene Jr MD Noninvasive Vascular Diagnostic Testing Part Il The Cerebrovascular Examination Physicians MarketPlace February 1989 pp 5 20 Strandness D Eugene Jr The Use of Ultrasound in the Evaluation of Peripheral Vascular Disease Progress in Cardiovascular Diseases 20 N 6 May June 1978 403 420 Barnes Robert W MD Office Doppler Techniques in Vascular Disease The Journal of Family Practice 13 N 5 1981 711 720 Barnes Robert W MD Lee Nix and Stanley E Rittgers PhD Audible Interpretation of Carotid Doppler Signals Arch Surg 116 September 1981 1185 1188 Car
55. f such damage is found do not use the probe Your dealer will advice you if the probe can be repaired 17 1 1 Periodical inspection Perform an examination of the probe before use and just after each disinfection or sterilisation for visible cracks and leaks If such damage is found do not use the probe Your dealer will advice you if the probe can be repaired 17 1 2 Precautions of storage To prevent the probe damage the probe must not be bent and wound tightly 17 1 3 Reuse life Perform an examination of the probe before use and just after each disinfection for visible cracks and leaks If such damage is found do not use the probe Your dealer will advice you if the probe can be repaired Before the use of the probe when the probe is just connected to the machine check the sound level If the sound level is high it means that the probe is damaged So do not use the probe Your dealer will advice you if the probe can be repaired 01 274 H 75 Atys m dical USER S MANUAL BASIC 17 2 Photo plethysmography sensors The sensors come in contact with intact skin The risk of infection is low so the sensors need only be cleaned and low level disinfected between patients Only FDA cleared cleaning agents must be used The user must refer to the labeling instructions provided by the manufacturer of the cleaning agents Only FDA cleared low level disinfectant agents must be used The user must refer to the labeling instructions provided by
56. figuration Date and Time Unit configuration New Archive Close Archive Archives 4 archives 32 images These two lines are not displayed simultaneously 13 1 Side From the acquisition program pressing the QuickButton two times allows to change the displayed side This is valid under the following condition a side must have been selected in the Select vessel configuration panel 13 2 Select vessel It is possible to display the name of the studied vessel This name can be selected in a list To select the name of the vessel the following operations are to be performed Press the QuickButton from the acquisition program to display the configuration menu With the QuickButton select Select vessel Press the QuickButton to validate The cursor is on the territory field To modify the territory press the QuickButton Turn the QuickButton to change the territory lower limbs Lowers upper limbs Uppers miscellaneous cervical pressure in lower limb Lowers W Pressure pressure in upper limb Uppers W Pressure Press the QuickButton to validate your choice e Turning the QuickButton move the cursor to the side field Press the QuickButton to validate Turn the QuickButton to select the side Press the QuickButton to validate e Turn the QuickButton to select the name of the vessel Press the QuickButton to validate your choice e Once the vessel name is validated the Select vessel
57. fitted with the WinAtys software An empty examination will have been selected in the WinAtys software The Connection Disconnection icon of WinAtys must be activated Archive menu Print Full Archive put the cursor on Print Full Archive and press the QuickButton Print all the images of the archive on the integrated thermal printer of the BASIC Menu archives Exit put the cursor on Exit and press the QuickButton Return to the configuration menu 01 274 H 63 A tys m dical USER S MANUAL BASIC 12 4 Storage capacity The memory capacity is 120 images into 16 archives at most 12 4 1 Archive full When an archive is full after the storage of the 16 image the following message is displayed Archive FULL Archive closed Do you want Open a new archive Continue without archiving You can either open a new archive or continue without archive Put the cursor on the selected option and press the QuickButton Continue without archiving Allows to resume the examination without archiving Once the above message is displayed press the QuickButton to continue without archiving Open new archive Allows to open a new archive to continue the storage of the examination results 12 5 Storage memory full After the storage of the 120 image the following message is displayed Archives FULL Do you want Clear oldest archive Continue without archiving Ignore You can either clear the oldest archive co
58. go back to the beginning of the V R T Here press Null to start a new V R T Enter to select other examination 9 2 Printing Comment The refilling time is calculated from the end of the flex exercises up to 9 3 Adjustment During the acquisition the user performs the following adjustment e Adjustment of the location of the zero line 01 274 H 51 A tys m dical USER S MANUAL BASIC 9 4 Examination with a tourniquet If the exam results are abnormal lt 20 s repeat the exam with a tourniquet on the patient s thigh The tourniquet test is necessary only if the right leg left leg or both legs tests are abnormal Wrap a 12 cm pressure cuff on the right and left patient s thigh These cuffs are not inflated by the BASIC They must be inflated by the user Repeat the V R T as previously 9 5 Limitations of the V R T Because the PPG probes are very sensitive to light and movement it is important to position them correctly Make sure that the probes are not placed on the bone and that they make good contact with the skin Patients with severe venous disease may have minimal venous emptying because of immediate back flow between dorsal flexions A venous thrombosis may also limit venous emptying Performing the flex exercises may be difficult for some patients It may be necessary to manually compress the patient s calves to empty the veins 01 274 H 52 A tys m dical US
59. he default value you start to inflate the cuff up to 100 mmHg and then you resume the inflating up to the real occlusion pressure by releasing and pressing again the foot pedal Release the foot pedal when the occlusion is performed the Doppler signal has disappeared e Press Pedal You must press the foot pedal all along the inflating e As the pressure cuff deflates the BASIC records the returning waveform During the deflating the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen 01 274 H 58 A tys m dical USER S MANUAL BASIC e The systolic pressure value is displayed on the upper left hand side corner beside the label Pres The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on another location of the cursor e If the left brachial pressure is lower than the right one Press Null to return to the acquisition screen without printing and without saving the left brachial pressure e If the left brachial pressure is higher than the right one Press Pedal to print and save the left brachial pressure The right brachial pressure is erased The saved brachial pressure is the one that is used for the ABI calculation After the printout the BASIC is ready for another
60. his effect is very low with peripheral Doppler because the ultrasonic power is very low and is constant It is not controlled by the user Atys has always endeavoured to use as low an ultrasonic power output for our products as is practical All power levels are significantly below those currently established by the FDA as limits above which specific review is necessary 1 10 Adverse effects Major governing bodies in ultrasound have issued statements to the effect that there are no known adverse effects from the use of diagnostic ultrasound However exposure should always be limited As Low As Reasonably Achievable ALARA principle 01 274 H 12 Atys m dical 2 SYMBOLS USER S MANUAL BASIC 2 1 Symbols used on the keyboard Icons used on the BASIC and in the user s manual Icons Name of the key 4 8 Probe aS Sign SY Filter TY LE Zero line Operating mode Null Sweep Amplitude DD amp Pedal 2 2 Symbols used on printing 28 02 00 14h54mn07s N 4M Filter Artery 1 10 mm e S41KHz 40cm s Spee 0 4s cm me 118ks 26 W 77 222 S systole marker D diastole marker 01 274 H 13 A tys m dical USER S MANUAL BASIC 3 SETTING 3 1 Console Probe case ENON N a s lt gt bas we Unit holder PK Switch ON OFF Case for single foot pedal and power cord IEC SOCKET A FFF A
61. ically The deflation occurs X seconds deflation delay after the end of the inflation So during this time if the input occlusion pressure is not high enough it is possible to resume the inflation without deflating the cuff To do so release the Pedal and just after press again the Pedal the inflation is resumed You can release the Pedal as soon as the occlusion is reached The deflation occurs X seconds deflation delay after the end of the inflation If the occlusion pressure is equal to 300 mmHg X 0 Otherwise the deflation delay can be equal to 1 to 6 s The adjustment of this delay is performed in the Unit configuration menu see 13 6 e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure value is displayed on the upper left hand side corner The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on another location of the cursor e When the acquisition window is frozen it is possible to go to the configuration menu by pressing the QuickButton You may have to go to the configuration menu to change the label of the vessel e Press Null to retu
62. illed cuff to record changes of blood volume in a limb By wrapping the pressure cuff around different locations on patients legs arms or digits you can quickly assess blood flow at these locations Relative limb volume increases with each heartbeat PVR measures this increase and depicts it in a waveform PVR is used in conjunction with segmental blood pressures and Doppler waveform analysis to fully evaluate the patient with peripheral vascular disease 8 1 Start of the acquisition Secure a cuff on the location under examination Position the patient appropriately on his her back on the examining table You may elevate the patient s head with pillows for greater comfort For accurate exam results the patient must be warm The room temperature should be between 22 C and 25 C The patient must remain relaxed throughout the exam Remind the patient to remain still and to refrain from talking To perform the examination connect the cuff to the BASIC Select PVR pn1 in the examination menu e From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on PVR pn1 Press the QuickButton The BASIC returns automatically to the acquisition screen Select the artery mode with the Filter key 01 274 H 45 Atys m dical USER S
63. imize his her exposure to ultrasound and as well the patient s CAUTION To prevent fire and electrical hazards keep the BASIC out of rain water and humidity CAUTION The BASIC is not intended to be used on non intact skin 01 274 H 3 A tys m dical USER S MANUAL 1 gt BASIC CONTENTS FOREWORD 1 1 Hardware components of the BASIC 1 2 Indications for use 1 3 Contraindications 1 4 Precautions and warnings 1 5 Customer responsibility 1 6 Patients and examiners safety 1 7 Serial number 1 8 Validity of the calculated indices 1 9 Factors influencing ultrasound power output 1 10 Adverse effects SYMBOLS 2 1 Symbols used on the keyboard 2 2 Symbols used on printing SETTING 3 1 Console 3 2 Mains connection 3 3 Probes and sensors 3 3 1 Probes 3 3 2 Infrared sensors 3 3 3 Cuffs 3 4 Screen 3 5 Keyboard 3 6 Paper and printing 3 6 1 Local printing 3 7 Sound Doppler only 3 8 Foot switch 3 9 Headphones 3 10 Transportation OPERATION 4 1 Objects on the acquisition screen 4 1 1 Curve 4 1 2 Grid 4 1 3 Vertical unit 4 1 4 Horizontal unit Time scale 4 1 5 Examination 4 1 6 Filter 4 1 7 Flow direction 4 1 8 Printer operating mode 4 1 9 Message 01274H 11 11 11 11 12 12 12 12 13 13 13 14 A tys m dical USER S MANUAL u LA a BASIC 4 1 10 Indices 4 1 11 Clock 4 1 12 Cine loop indicator 4 1 13
64. is frozen e The systolic pressure and ABI RPI value are displayed on the upper left hand side corner beside the label Pres The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on another location of the cursor e Press Null to return to the acquisition screen without printing Pedal to print and save the ankle pressure The BASIC is ready for another pressure measurement See 7 6 2 to select properly the printout option 01 274 H 59 A tys m dical USER S MANUAL BASIC 11 4 Left ankle systolic pressure After this measurement the left ABI RPI will be calculated Secure a cuff around the patient s left ankle Use the 8 MHz probe Turn the QuickButton to select the proper vessel name You will not find ankle you can select for example posterior tibial or dorsalis pedis Press twice the QuickButton to display left Press Pedal Input the occlusion pressure turning the QuickButton The 100 mmHg default value could be convenient If you keep the default value you start to inflate the cuff up to 100 mmHg and then you resume the inflating up to the real occlusion pressure by releasing and pressing again the foot pedal Release the foot pedal when the occlusion is performed the Doppler signal has disappeared Press Pedal You must press the foot pedal all along the inflating As the pressur
65. ities while using the PPG ph1 A cuff is secured around the arm leg or digit you are examining The arterial infrared sensor is used to locate a vessel distal to the cuff in one digit or in one toe The cuff is inflated to stop the blood flow As the pressure cuff deflates the BASIC infrared sensor records the returning waveform The pressure corresponding to the return of the blood flow is the systolic pressure The level of measurement is determined by the site of the compressing cuff not the flow detection site It is the intraluminal pressure under the cuff that must be overcome to stop flow 7 6 1 Performing the pressure measurement in the one channel photo plethysmography mode Connect the cuff to the BASIC Secure the cuff on the arm leg or digit you are examining Place or tape an arterial infrared sensor on a digit or toe depending on the location you are testing 01 274 H 40 A tys m dical USER S MANUAL BASIC If not already done select PPG ph1 examination from examination selection menu From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on PPG ph1 Press the QuickButton The BASIC returns automatically to the acquisition screen Obtain a good quality waveform Press Null to enter the pressure measuremen
66. l characteristics 14 10 Safety 14 11 Regulation CLINICAL SAFETY OF ULTRASOUND AND THE ALARA PRINCIPLE CLINICAL ACCURACY 16 1 Doppler 16 1 1 Accuracy of the measurement 16 1 2 Range of Doppler controls 16 2 Photo sensors 16 3 Pneumo module CLEANING DISINFECTION AND STERILISATION OF ATYS EQUIPMENT 17 1 Doppler probes 17 1 1 Periodical inspection 17 1 2 Precautions of storage 17 1 3 Reuse life 17 2 Photo plethysmography sensors 17 3 Cuffs 17 4 Console 17 5 Screen 17 6 After sales service PACKING THE BASIC FOR SHIPPING WASTING OF THE PACKAGE AND OF THE BASIC CHARACTERISTICS OF THE PRESSURE CUFFS UNDERSTANDING THE EXAMINATION RESULTS 21 1 Arterial Doppler 69 69 70 70 70 70 70 70 70 70 70 71 71 71 72 73 73 73 73 73 73 76 76 77 78 78 A tys m dical USER S MANUAL 21 2 21 3 21 4 21 5 21 6 21 7 BASIC Arterial photoplethysmography Air pneumoplethysmography Pulse volume recording Understanding the ABI test Understanding the segmental pressure test Understanding the digital test Understanding the Venous Reflux Test V R T 22 BIBLIOGRAPHY 01 274 H 80 81 82 82 82 83 84 A tys m dical USER S MANUAL BASIC 1 FOREWORD This user s manual is for three models of BASIC e BASIC 1 4 and 8 MHz Doppler e BASIC 2 4 and 8 MHz Doppler fitted with a two channel photo plethysmograph e BASIC 3 4 and 8 MHz Doppler fitted with a two chan
67. lity you can listen to the arterial or venous blood at various locations on a patient s limb and view the corresponding waveforms You can also obtain systolic pressures at a number of different locations on arms legs and digits Use the 4 MHz probe on larger patients or when examining blood vessels that run deeper in the body The lower frequency 4 MHz ultrasound waves penetrate deeper into the body Use the 8 MHz Doppler probe on smaller patients or when examining blood vessels that run closer to the surface The higher 8 MHz ultrasound waves do not penetrate deeper into the body The list below may help you to choose the appropriate probe for the artery you are examining 4 MHz probe 8 MHz Common femoralartery Posterior tibial artery Superficial femoral artery Dorsalis pedis artery Popliteal artery Peronal artery Subclavian artery Brachial artery Radial artery Ulnar artery The Doppler probe emits ultrasound waves that hit the blood cells flowing through a vessel These ultrasound waves bounce off the blood cells and return to the probe The reflected ultrasound waves change in frequency proportional to the velocity of the blood flow This frequency change is known as the Doppler shift _2feVcosd Af C Where Af is the frequency change that occurs when the ultrasound waves reflect off moving blood cells fe is the emission frequency fe is equal to 4 or 8 MHZ V is the velocity of the moving bl
68. lsen Ernest N PhD MD Ultrasound Physics for the Physician A Brief Review Journal of Clinical Ultrasound 3 N 1 pp 69 75 Jiunta Thomas P DPM and Gary L Dockery DPM Doppler Ultrasound Diagnosis of Venous Disease Journal of the American Podiatry Association 71 N 10 October 1981 551 556 Yu John S BBc RVT and A J Salvian MD FRCS A comparison of Penile Brachial Indices Using Doppler and Photoplethysmographic Techniques Bruit 10 April 1986 60 62 Harris John MS FRACS FRCS FACS et al Clinical and Photoplethysmographic Assessment of Thoracic Outlet Arterial Compression Journal of Vascular Technology 13 January 1989 20 23 Lee Bok Y MD FACS et al Assessment of the Healing Potentials of Ulcers of the Skin by Photoplethysmography Surgery Gynecology amp Obstetrics 148 February 1979 2 9 Standness D Eugene Jr MD and David S Sumner MD Hemodynamics for Surgeons New York Grune amp Stratton 1975 Tripolitis A J MD et al The Influence of Limb Elevation Examination Technique and Outflow System Design on Venous Plethysmography Angiology Vol 31 N 3 March 1980 pp 154 162 01 274 H 85
69. lvular sufficiency by performing a Venous Reflux Test See 9 The PPG Ph2 is used for the digital test In this exam the digits are tested bilaterally This allows for immediate bilateral comparison The PPG sensors comprise an infrared light emitter and a receptor The light emitter directs infrared light into the skin The receptor measured the amount of light reflected off the blood cells The amount of blood in skin tissue changes with each heart contraction The PPG sensors measure this change and depict it in a waveform The greater the change in tissue perfusion from each heart beat the more mountainous the waveform For better visualisation you may need to increase the waveform size with the amplitude key However the more you increase the size the poorer the blood supply is to the area being examined In this test the amplitude key allows to adjust the gain The gain values are 1 2 5 10 20 50 and 125 If the gain is equal to 125 and the waveform is still weak small amplitude for most of the exam sites the tissue perfusion is very low Conversely if the waveform is strong large amplitude for most of the sites examined the tissue perfusion is correct 6 1 Start of the acquisition To perform PPG ph2 connect the two arterial infrared sensors to the two connectors on the BASIC The connector in the lower right hand side corner is for the right side The other connector is for the left side Place or tape the
70. n The BASIC returns automatically to the acquisition screen In the acquisition screen you can switch from the 4 MHz probe to the 8 MHz probe by pressing the following key Use the Doppler probe to locate an artery distal to the cuff Obtain a good quality clear and maximum amplitude Doppler waveform e Press Null to enter the pressure measurement mode The following message is displayed Adjust Vess Name NEXT PED It means that you can adjust the name and side of the vessel and then press Pedal to validate it and to go to the next step e f necessary change the name of the vessel turning counterclockwise or pressing the QuickButton According to the selected vessel territory you may have to turn the QuickButton on 90 before displaying any vessel name If you want just to change the side press twice the QuickButton e Press Pedal to validate the name of the vessel The following message is displayed Occlusion PRESS NEXT PED It means that you can now adjust the value of the cuff pressure that is supposed to be equal to the occlusion pressure Then the next step is to press pedal to inflate the cuff 01 274 H 30 Atys m dical USER S MANUAL BASIC The default value of the occlusion pressure is 100 mmHg It is displayed in the upper left hand corner beside the label Occl It can be adjusted turning the QuickButton The occlusion value cannot be greater than 300 mmHg The occlusion pre
71. n the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure value is displayed on the upper left hand side corner beside the label Pres The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on another location of the cursor 01 274H o Atys m dical USER S MANUAL BASIC e If the left brachial pressure is lower than the right one Press Null to return to the acquisition screen without printing and without saving the left brachial pressure e If the left brachial pressure is higher than the right one Press Pedal to print and save the left brachial pressure The right brachial pressure is erased The saved brachial pressure is the one that is used for the ABI calculation After the printout the BASIC is ready for another pressure measurement Comment Unless there are extenuating circumstances the brachial pressures should be within 20 mmHg of each other If the pressure difference is greater than 20 mmHg retesting is recommended 10 3 Right ankle systolic pressure After this measurement the right ABI RPI will be calculated Secure a cuff around the patient s right ankle Tape an infrared arterial sensor on a patient s right toe e Turn the
72. n as the occlusion is reached The occlusion pressure must be 20 to 30 mmHg higher than the systolic pressure e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure value is displayed on the upper left hand side corner The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the value of the pressure on another location of the cursor e Press Null to return to the acquisition screen without printing Pedal to print and save the brachial pressure The saved brachial pressure is the one that is used for the ABI calculation After the printout the BASIC is ready for another pressure measurement See 7 6 2 to select properly the printout option 11 2 Left brachial systolic pressure The left brachial pressure is measured just to compare it with the right one e Secure a cuff around the patient s left arm e Use the 8 MHz probe Turn the QuickButton to select the proper vessel name brachial Press twice the QuickButton to display left instead of right Press Pedal Input the occlusion pressure turning the QuickButton The 100 mmHg default value could be convenient If you keep t
73. n buzz At the first beep have the patient begin the flex exercises There are nine beeps Patient should flex his her feet at each beep about every 1 5 s 01 274 H 50 A tys m dical USER S MANUAL BASIC For accurate exam results the venous system must be emptied of blood To empty the venous system it is more important that the patient perform full flex exercises than he she performs all 9 exercises e Atthe end of the flex exercise the following message is displayed 4 recording wait Have the patient relax his her feet and rest while the veins refill with blood during around 1 min e After the rest period the acquisition is frozen For each side the TO time outflow and TH half time outflow indices are displayed They are calculated at the position of the cursors It is possible to move the cursor turning the QuickButton Press the QuickButton to switch from one cursor to the other The following message is displayed 5 lt PEDAL gt to print e Press Pedal to print the display Null to go back to the beginning of the V R T Then press Null to start a new V R T Enter to select other examination If you press Pedal during the flex exercises or the rest period the acquisition will be finished The screen is frozen Then press e Pedal to print the display e Enter to select and turn the QuickButton to move the cursor e Null to
74. ne loop indicator The BASIC is fitted with a buffer The buffer can store up to 1 min duration of an examination The indicator is one or several stars between two brackets The stars indicate the location of the displayed window in the entire recording 4 1 13 Side indication It is automatically displayed for the following examinations e PPG Ph2 two channel Photo Plethysmography e VRT Venous Reflux Test For these two examinations the side indication is displayed on the left hand side of screen as follows e Right e Left The right side signal is displayed above Right The left side signal is displayed below Left The right side signal comes from the right hand side sensor it is connected on the right connector closest to the lower right hand corner of the machine The left side signal comes from the left hand side sensor it is connected to the left hand side connector For the other tests the side may be input by the user In this case it is displayed on the upper right hand corner of the screen 4 1 14 Name The name of the vessel may be input by the user It is displayed on the upper right hand corner of the screen see 13 2 01 274 H 25 A tys m dical USER S MANUAL BASIC 4 2 Adjustments and controls The general controls are done by the Pedal and the Null keys Use the QuickButton to display the configuration menu and to select item from the menu You can press the Qui
75. nel photo plethysmograph and a one channel pneumo plethysmograph MODULE BASIC 1 BASIC 2 BASIC 3 Doppler 4 and 8 MHz yes yes yes Photo plethysmography two channels no yes yes Pneumo plethysmography no no yes EXAMINATION BASIC 1 BASIC 2 BASIC 3 Velocity measurement yes yes yes Digital test Photo plethysmography no yes yes Venous reflux test no yes yes Pulse volume recording no no yes Ankle Brachial index no no yes Pressure in digit and limb no no yes Systolic pressure examination no no yes 1 1 Hardware components of the BASIC The BASIC consists of the following components e Doppler and plethysmography processing unit e Remote control e Integrated thermal printer e Integrated LCD e Footswitch e 4and 8 MHz probes e Arterial and venous photo sensors BASIC 2 and BASIC 3 e Pressure cuffs BASIC 3 The cuffs are the only BASIC accessories Their specifications are reported in 20 1 2 Indications for use When a patient s history and symptoms indicate a possible vascular problem the BASIC can be used by a trained medical personnel to e Confirm the indication e Locate the site of the vascular irregularity e Determine the severity of the problem 01 274 H 9 Atys m dical USER S MANUAL BASIC In each mode the following exams can be performed e Doppler mode use to evaluate blood flow in the arteries and veins and as a stethoscope to examine systolic
76. nterclockwise to put the cursor on Examination if not frozen e Press the QuickButton e Turn the QuickButton to put the cursor on DOP 4M or DOP 8M DOP 4M means 4 MHz Doppler DOP 8M means Doppler 8 MHz e Press the QuickButton The BASIC returns automatically to the acquisition screen On the acquisition screen you can switch from the 4 MHz probe to the 8 MHz probe by pressing the following key With the Doppler probe locate the blood vessel that you want to examine You may have to experiment with the probe until you find the best signal Be sure to hold the probe at a 45 to 60 angle The probe angle is very important in obtaining a good waveform In the Doppler shift equation the change in frequency is proportional to the incident angle Do not press too hard with the probe Pushing too hard can occlude the vessel Use a firm but gentle touch 45 to 60 The audible and the visual Doppler signals provide complementary information and both are important to your analysis Do not rely on just one of theses results in your screening procedure At any time if the screen is frozen pressing the Null key can start the acquisition again CAUTION During the acquisition with BASIC 3 pressing Null allows to enter the pressure measurement mode With BASIC 1 and BASIC 2 If you press Null during the acquisition the pressure measurement screen is displayed but the pressure measurement is not ac
77. ntinue without archiving or clear any archive Put the cursor on the selected option and press the QuickButton Clear oldest archive Allows to clear the oldest archive All the pictures of this archive are then lost Continue without archiving Allows to resume the examination without archiving Once the above message is displayed press the QuickButton to continue without archiving Ignore The memory is full but the user has then the possibility to clear any archive not necessary the oldest one When there are 120 images in the memory the following message is displayed as soon as the user tries to store a new 121 image Archives FULL Do you want Clear oldest archive Print You can either clear the oldest archive or printout the display Put the cursor on the selected option and press the QuickButton Clear oldest archive Allows to clear the oldest archive All the pictures of this archive are then lost Print Allows to print out the display 01 274H TT A tys m dical USER S MANUAL BASIC 13 CONFIGURATION The configuration menus are used to Select a vessel name Select an examination Define a probe or sensor configuration Adjust the date and time Define the unit configuration Process archives see 12 From the acquisition program press the QuickButton to reach the configuration menu Exit Side left right or blank Select vessel Examination if not frozen Probe con
78. ood cells 0 is the angle of the ultrasound beam to the blood flow direction C is the ultrasound velocity in the tissue The BASIC records the frequency shifts and calculates the velocity The loud speakers allow you to listen to these frequency shifts The various flow velocities are averaged and displayed as a single continuous waveform As the average velocity changes the waveform height changes proportionally Two important parameters affect the audible signal frequency and strength e The frequency pitch depends on the velocity of the moving blood cells the faster the cells move the higher the frequency shift e The volume loudness of a given frequency depends on how many blood cells are moving at a given velocity 5 1 Start of the acquisition Prepare the patient for the Doppler examination Position him her comfortably on the examining table You should have access to the blood vessel you are examining Apply a generous amount of conducting gel to the location For accurate exam results the patient must be warm The room temperature should be between 22 C and 25 C The patient must remain relaxed throughout the exam Remind the patient to remain still and to refrain from talking 01 274 H 27 Atys m dical USER S MANUAL BASIC Select Doppler examination from examination selection menu e From the acquisition screen press the QuickButton The configuration menu is displayed e Turn the QuickButton cou
79. op blood flow Then as the cuff deflates the Doppler probe or the arterial photoplethysmography sensor detects the returning blood flow The systolic blood pressure is measured at different levels in the upper and lower extremities to determine the pressure differences or ratios in the segments between two cuff locations Large pressure differences indicate arterial disease The important data are not the absolute value of the pressures but the pressure differences or ratios The BASIC performs the following types of automatic tests e ABI Anckle Brachial Index test with Doppler screens a patient for arterial disease in the legs by using Doppler ultrasound e ABI Anckle Brachial Index test with photo plethysmography screens a patient for arterial disease in the legs by using photo plethysmography e Penile pressure test e Segmental test with Doppler isolates and characterizes the severity of arterial disease in the legs by using Doppler ultrasound e Segmental test with photo plethysmography isolates and characterizes the severity of arterial disease in the legs by using photo plethysmography e Pulse volume recording with photo or pneumo plethysmography e Digital test evaluates the arterial blood flow in the hands or feet e Venous reflux test provides an indication of incompetent valves in the superficial and deep veins of the legs e Direct Doppler carotid test evaluates possible stenosis of the common carotid internal caroti
80. owing vessel territories is selected Upper Lower Cervical Miscellaneous e Tothe pressure measurement screen if one of the following vessel territories is selected Pres Lower pressure in lower limb Pres Upper pressure in upper limb In this case the name of the next vessel in the list is displayed Follow the instructions displayed on the screen to continue the pressure measurement validation of the vessel name adjustment of the occlusion pressure e Press Null to return to the acquisition screen without printing Pedal to print the pressure 01 274 H 43 Atys m dical USER S MANUAL BASIC 7 7 Limitation of the pressure measurement with PPG Because the PPG sensor is very sensitive to light and movement it is possible to obtain incorrect systolic pressures if a patient moves or talks Incorrect systolic pressures may also be obtained from a moderate or severely diseased patient because their capillary blood flow is often compromised If either of these cases occurs you will have to use the Doppler mode to obtain systolic pressure 01 274 H 44 A tys m dical USER S MANUAL BASIC 8 ONE CHANNEL PNEUMO PLETHYSMOGRAPHY PULSE VOLUME RECORDING Use the one channel pneumo plethysmography arterial mode to record arterial pulse wave shape and amplitude at various limb or digit locations This information allows you to assess the circulation at those locations PVR uses air f
81. regnancy the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use No confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound instruments have ever been reported Although the possibility exists that such biological effects may be identified in the future current data indicates that the benefits to patients of the prudent use of diagnostic ultrasound outweighs the risks if any that may be present The exposure at ultrasound should always be limited to As Low As Reasonably Achievable ALARA principle You can control the exposure to ultrasound by limiting the duration of the exposure Atys has always endeavoured to use as low an ultrasonic power output for our products as is practical All power levels are significantly below those currently established by the FDA as limits above which specific review is necessary Ultrasound power output measurements Power measurements acoustic measurements and mathematical calculations were carried out by TIMUG EV Villiper Allee 8 D 53125 Bonn GERMANY A test report is available Measurements for the calculation of spatial peak temporal average intensity lspra were carried out using calibrated PCDF hydrophone probes following the instructions and standards of the American Institute of Ultrasound in Medicine AIUM For the report three measurements are made here one measurem
82. resentative The BASIC must not be operated in presence of flammable anesthetics The BASIC must not be operated or stored outside the specified environment conditions 01 274 H 11 A tys m dical USER S MANUAL BASIC Inspect the power cable for signs of fraying or other damage before each setting Do not operate the system if the power plug or cord is damaged In 120V operation use a 125V 10A and UL power cable with ground and place the voltage selector on 120V In 240V operation use a 250V 5A and IEC power cable with ground and place the voltage selector on 240V In USA only FDA cleared blood pressure cuffs must be connected to the BASIC The characteristics of the cuffs compatible with the BASIC are reported in 20 1 7 Serial number Write here the serial number of your BASIC It is on the backside on the identification label ws 1 8 Validity of the calculated indices The displayed values of the indices are available only under certain conditions of good quality measurements These conditions can be identified in the curve on the screen as on the printing For further details read section OPERATION 1 9 Factors influencing ultrasound power output With continuous wave ultrasound a transducer sends continuously ultrasound into tissue and a second transducer receives continuously the reflected back ultrasound wave Ultrasound waves dissipate energy in the form of heat and can therefore cause tissue warming T
83. rn to the Doppler examination window without printing Pedal to print the pressure At any time during the examination you can press Null to leave the pressure measurement window and go back to the Doppler acquisition window During the inflation and deflate mode it is possible To leave the pressure measurement window and deflate the cuff by pressing Null To deflate quickly the cuff by pressing Pedal the pressure measurement window remains displayed 01 274 H 42 A tys m dical USER S MANUAL BASIC 7 6 2 Printout As far as the pressure examination is concerned two kinds of printout are available e A printout of the pressure values and of the curves Doppler and pressure e A printout of the pressure values alone The selection of the kind of printout is performed in the Unit configuration menu see 13 6 Bressuire Inflation curve Occlusion pressure Deflation 30 02 00 18h52mn35s Photo 1 5OmmHg cm Pee ea eee mig 196 I tu liy A i 147 First part Photo signal Recording of the No photo signal because of the Returning of the photo photo signal occlusion signal Systolic pressure corresponds to the returning of the photo signal The above printout is obtained with a low sweep speed gt gt gt This key is used to adjust the sweep speed Once the print out is performed the BASIC returns to e The acquisition screen if one of the foll
84. rsor in order to get the value of the pressure on another location of the cursor e Press Null to return to the acquisition screen without printing Pedal to print the ankle pressure The BASIC is ready for another pressure measurement See 7 6 2 to select properly the printout option 01 274 H 56 A tys m dical USER S MANUAL BASIC 11 ABI TEST WITH DOPPLER This test allows to screen a patient for arterial disease in the lower extremities This exam uses e A Doppler probe to sense the patient s blood flow e A pressure cuff to measure the systolic pressure This test determines the Ankle Brachial Index In the BASIC ABI is label RPI Residual Pressure Index ABI Ankle systolic pressure Highest brachial pressure The following measurements are to be performed successively e Right brachial systolic pressure e Left brachial systolic pressure e Right ankle systolic pressure e Left ankle systolic pressure The RPI Residual Pressure Index is more general than the ABI RPI systolic pressure of any location Highest brachial pressure For RPI test you can follow the ABI procedure but the location of the cuff is different 11 1 Right brachial systolic pressure Secure a cuff around the patient s right arm The procedure is the same as described in 5 6 Use the 8 MHz probe If not already done select DOP 8 examination from examination selection menu e From the acquisition screen pre
85. ry 1987 pp 81 84 Felix W Robert Jr Noninvasive Diagnosis of Peripheral Vascular Disease New York Raven Press 1988 Feussmer John R MD and David B Matchar MD When and How to Study the Carotid Arteries Annals of Internarl Medicine 109 1988 805 818 Flinn William R MD Charles S O Mara MD Linda K Peterson RN Donna Blackburn RN and James S T Yao MD PhD The Use of Photoplethysmography in the Assessment of Venous Insufficiency Practical Noninvasive Vascular Diagnosis 2 Edition Chicago IL Year Book Medical Publishers 1987 pp 486 505 Gutierrez Irineo A MD Andrew A Gage MD and Paula A Makula Toe Pulse Study in Ischemic Arterial Disease of the Legs Surgery Gynecology amp Obbstetrics 153 December 1981 889 892 Hershey Falls B MD Robert W Barnes MD and David S Summer MD eds Noninvasive Diagnosis of Vascular Disease Pasadena CA Appleton Davies Inc 1984 Kempczinski Richard F MD and James S T Yao MD PHD eds Practical Noninvasive Vascular Diagnosis Chicago Year Book Medical Publishers Inc 1982 McBride Kevin J MD Thomas F O Donnell Jr MD Stephen G Pauker MD Victor A Millan MD and Allan D Callow MD Venous volume displacement plethysmography Its diagnostic value in deep venous thrombosis as determined by receiver operator characteristic curves Bulletin of the Texas Heart Institute Vol 8 N 4 Dec 1981 Nicolaid
86. safety reason During the inflation the following message is displayed Inflating PED Once the input occlusion pressure is reached the inflation stops automatically Nevertheless if you realise that the input pressure is not high enough for the occlusion you can resume the inflation you have just to release the Pedal and just after press again the Pedal You have to press the Pedal until the occlusion is reached In this case you have to release the Pedal to stop the inflation Second option you do not adjust the occlusion pressure you keep the default value of 100 mmHg Then you press Pedal to start the inflation Beeps must be heard before starting the pressure measurement they indicate that the photo plethysmography signal is stable You have to press Pedal all along the inflation for safety reason During the inflation the following message is displayed Inflating PED Once the 100 mmHg cuff pressure is reached the inflation stops automatically The cuff pressure is likely to be insufficient for an occlusion You may have to resume the inflation To do so you have just to release the Pedal and just after press again the Pedal You have to press the Pedal until the occlusion is reached In this case you have to release the Pedal to stop the inflation 01 274 H 41 A tys m dical USER S MANUAL BASIC e After the inflation the BASIC deflates the cuff automat
87. solution 2 dots mm Control of the contrast on the front panel 14 7 Environmental characteristics Operating 10 to 30 C 0 100 Hr no condensation Non operating 10 to 50 C 0 100 Hr no condensation 14 8 Electrical characteristics 110 VAC 7 13 50 60 Hz 220 VAC 7 13 50 60 Hz Power and fuses see indications on the appliance 01 274 H 70 A tys m dical USER S MANUAL BASIC 14 9 Mechanical characteristics Dimensions Width 28 cm Depth 29 cm Height 16 cm Weight 8 5 kg 14 10 Safety BASIC is compliant with IEC 601 1 international code of safety Class 1 type BF appliance Mechanical protection index IP20 Water leaktightness height of the probes 20 mm 14 11 Regulation CE 0459 BASIC is compliant with the following international code EN 55011 CISPR11 IEC 801 2 3 4 5 BASIC is compliant with the CE mark EMC BASIC is designed and manufacture with the ISO9001 EN46001 quality system 01274H 71 A tys m dical USER S MANUAL BASIC 15 CLINICAL SAFETY OF ULTRASOUND AND THE ALARA PRINCIPLE The American Institute of Ultrasound in Medicine has addressed the issue of the safety of ultrasound The Institute issued the following statement concerning the clinical safety of ultrasound as of October 1983 Diagnostic ultrasound has been in use for 25 years Given its known benefits and recognised efficacy for medical diagnosis including use during human p
88. ss the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on DOP 8 Press the QuickButton The BASIC returns automatically to the acquisition screen f not already done select the vessel territory Lowers W pressure side right and name brachial e From the acquisition screen press the QuickButton The configuration menu is displayed e Turn the QuickButton counterclockwise to put the cursor on Select vessel e Press the QuickButton The cursor is on the vessel territory e Press the QuickButton and turn it to select the lower limb territory with pressure measurement Lowers W Pressure e Press the QuickButton to validate e To change the vessel side put the cursor on the side field Press the QuickButton to validate Turn the QuickButton to select the side Press the QuickButton to validate e Turn the QuickButton to put the cursor on brachial e Press the QuickButton to validate The BASIC returns to the acquisition screen Position the Doppler probe on an artery distal to the cuff Obtain a good quality clear and maximum amplitude Doppler waveform You must hold the Doppler probe steady Resting your hand against the patient s arm often helps e Press Null to enter the pressure measurement mode The following message is displayed Adjust
89. ssure measurement See 7 6 2 to select properly the printout option 10 4 Left ankle systolic pressure After this measurement the left ABI RPI will be calculated Secure a cuff around the patient s left ankle Tape a infrared arterial sensor on a patient s left toe e Turn the QuickButton to select the proper vessel name You will not find Ankle you can select for example Tibial e Press twice the QuickButton to display left e Press Pedal e Input the occlusion pressure turning the QuickButton The 100 mmHg default value could be convenient If you keep the default value you start to inflate the cuff up to 100 mmHg and then you resume the inflating up to the real occlusion pressure by releasing and pressing again the foot pedal Release the foot pedal when the occlusion is performed the photoplethysmography signal has disappeared e Press Pedal You must press the foot pedal all along the inflating e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure and the ABI RPI value are displayed on the upper left hand side corner beside the label Pres The cursor indicates the place where the pressure is calculated Turn the push QuickButton to move the cu
90. ssure must be 20 to 30 mmHg higher than the systolic pressure e At this stage you have two options First option you adjust the value of the occlusion pressure turning the QuickButton Then you press Pedal to start the inflation Beeps must be heard before starting the pressure measurement they indicate that the Doppler signal is stable You have to press Pedal all along the inflation During the inflation the following message is displayed Inflating PED Once the input occlusion pressure is reached the inflation stops automatically Nevertheless if you realise that the input pressure is not high enough you can resume the inflation you have just to release the Pedal and just after press again the Pedal You have to press the Pedal until the occlusion is reached In this case you have to release the Pedal to stop the inflation Second option You do not adjust the occlusion pressure you keep the default value of 100 mmHg Then you press Pedal to start the inflation Beeps must be heard before starting the pressure measurement they indicate that the Doppler signal is stable You have to press Pedal all along the inflation During the inflation the following message is displayed Inflating PED Once the 100 mmHg cuff pressure is reached the inflation stops automatically The cuff pressure is likely to be insufficient for an occlusion You may have to resume the inflation To do so
91. st be neither truncated nor too small Sweep speed adjustment The advised sweep speed is 0 4s cm Zero line adjustment Selection of the vessel name turning the QuickButton from the screen is not frozen or with the Select vessel menu e Selection of the printer operating mode the Immediate mode IMDT is advised 6 3 Acquisition quality The acquisition quality can be judged according to the following criteria e The number and the location one per cycle of the systole markers have to be correct e The displayed heart rate is a good indicator easy to check It must be steady the discrepancies between to successive cycles must not be greater than 10 and coherent with the patient heart rate If no systole markers are displayed and if the indices are not calculated it may be due to the selected amplitude Try to increase the value of the gain with the Amplitude key So the height of the displayed signal will be higher The Y axis scale must be chosen to take advantage of the full screen Nevertheless the waveform must not go out of the screen otherwise the calculations are not correct 6 4 Validation Display freezing When the display offers a satisfying quality the screen can be frozen by pressing Pedal Once the acquisition is frozen the curve is drawn again Markers point out the location of systoles The displayed index calculations concern the last proper cycle for which the systole markers are displaye
92. t is no longer on the screen Since the instrument prints only the data shown on the screen you must scroll to view the waveform you want to print The different calculations and parameters are then updated Once the acquisition is frozen you can turn the QuickButton counter clockwise to review the previous waveform It is also possible to change the sweep speed sign filter zero line position and amplitude 8 5 Printing Once the acquisition is frozen the screen can be printed out by pressing Pedal In the immediate printer operating mode the system returns automatically to the acquisition mode after the printout In the automatic printer operating mode the system does not return to the acquisition mode after the printout it remains frozen This allows several printouts after scrolling Press Null to unfreeze the acquisition If the continuous printer operating mode is selected press the Pedal key to print continuously Press again the Pedal to print the adjustment parameters and to stop the printing i Fe ae 00 01 19h3 mn41s PVR pn1 Filter Artery Scale 0 O2mmHg Speed 0 4s om i i LL i 54 Es BPM Ex ARE il ne io l LE 01274H 47 A tys m dical USER S MANUAL BASIC 9 VENOUS REFLUX TEST Use the Venous Reflux Test to evaluate valve competency of the patient s
93. t mode The following message is displayed Adjust Vess Name NEXT PED It means that you can adjust the name and side of the vessel and then press Pedal to validate it and to go to the next step If necessary change the name of the vessel turning counterclockwise or pressing the QuickButton According to the selected vessel territory you may have to turn the QuickButton on 90 before displaying any vessel name If you want just to change the side press twice the QuickButton Press Pedal to validate the name of the vessel The following message is displayed Occlusion PRESS NEXT PED It means that you can now adjust the value of the cuff pressure that is supposed to be equal to the occlusion pressure Then the next step is to press pedal to inflate the cuff The default value of the occlusion pressure is 100 mmHg It is displayed in the upper left hand corner beside the label Occl It can be adjusted turning the QuickButton The occlusion value cannot be greater than 300 mmHg The occlusion pressure must be 20 to 30 mmHg higher than the systolic pressure At this stage you have two options First option you adjust the value of the occlusion pressure turning the QuickButton Then you press Pedal to start the inflation Beeps must be heard before starting the pressure measurement they indicate that the photo plethysmography signal is stable You have to press Pedal all along the inflation for
94. te e Do all the necessary modifications e Press Null or select Exit and press Enter to leave the probe configuration panel e The configuration is automatically stored 13 4 4 Index list Symbol unit Function No index displayed at this place Sysv cm s Systolic Velocity DiaV cm s Diastolic Velocity SysF kHz Systolic Frequency DiaF kHz Diastolic Frequency S D Systolic Diatolic RI Resistance Index PI Pulsatility Index PI 2 Pulsatility Index 2 decimal Aver cm s Speed Average H R BPM Heart Rate Flow l min Flow rate Pres mmHg Pressure PlsL Plethysmo pulsatility Left PISR Plethysmo pulsatility Right Sym Plethysmo symetry L R RPI Resiudal Pressure Index The following three indices are automatically displayed during the V R T they cannot be selected in the probe configuration menus TO S Time Outflow TH s Half Time Outflow VO Venous Outflow 01 274 H 67 A tys m dical USER S MANUAL BASIC 13 5 Date and time To change the date and the time the following operations are to be performed From the acquisition screen press the QuickButton The configuration panel is then available Select the Date and Time with the QuickButton Press the QuickButton to validate Select the data to be modified turning the QuickButton Press the QuickButton to validate Change the value of the units or of the tens turning the QuickButton If the total value is not correct it is necessary to modify the
95. tion screen if one of the following vessel territories is selected Upper Lower Cervical Miscellaneous e the pressure measurement screen if one of the following vessel territories is selected Pres Lower pressure in lower limb Pres Upper pressure in upper limb In this case the name of the next vessel in the list is displayed Follow the instructions displayed on the screen to continue the pressure measurement validation of the vessel name adjustment of the occlusion pressure 01 274 H 32 A tys m dical USER S MANUAL BASIC 5 6 3 Segmental pressure If you want to perform a segmental pressure test in the legs it is advised to select the following vessel territory Lowers W Pressure When you perform the segmental pressure test you suspect a blockage of blood flow in a patient s leg With the test you are trying to find out e If there is a blockage in the leg arteries e How much blockage there is in the leg arteries e Where the blockage is located 5 6 4 Limitations of the pressure measurement with Doppler Doppler is an effective method of measuring systolic pressures but it does have a few limitations Calcium deposit and or partially hardened arteries can give false pressure readings In these cases it is recommended to obtain toe pressures and PVR waveforms Obese and overly muscular patients may show elevated pressures especially in thigh locations It is also important
96. tive So press the Null again to go back to your acquisition window 5 2 Adjustment During the acquisition the user performs the following adjustments Probe selection 4 or 8 MHz Sound volume adjustment Amplitude adjustment The waveform must not be truncated nor to small Sweep speed adjustment The advised value is 0 4s cm Zero line adjustment Sign adjustment The waveform must be above the zero line Filter selection The standard filter in arterial mode is Artery 1 Selection of the vessel name or side turning the QuickButton if the screen is not frozen or with the Select vessel menu you can reach this menu by pressing the QuickButton e The printer operating mode The Immediate mode IMDT is advised Generally the different adjustments are stored it is not necessary to modify them 01 274 H 28 Atys m dical USER S MANUAL BASIC 5 3 Acquisition quality The acquisition quality can be judged according to the following criteria e The number and the location one per cycle of the systole and diastole markers have to be correct e The displayed heart rate is a good indicator easy to check It must be steady the discrepancies between two successive cycles must not be greater than 10 and coherent with the patient heart rate 5 4 Validation Display freezing When the display offers a satisfying quality pressing Pedal freezes the screen Once the acquisition is frozen e The curve
97. tomatically to the acquisition screen f not already done select the vessel territory Lowers W pressure side right and name brachial e From the acquisition screen press the QuickButton The configuration menu is displayed e Turn the QuickButton counterclockwise to put the cursor on Select vessel e Press the QuickButton The cursor is on the vessel territory e Press the QuickButton and turn it to select the lower limb territory with pressure measurement Lowers W Pressure e Press the QuickButton to validate e To change the vessel side put the cursor on the side field Press the QuickButton to validate Turn the QuickButton to select the side Press the QuickButton to validate e Turn the QuickButton to put the cursor on brachial e Press the QuickButton to validate The BASIC returns to the acquisition screen e Press Null to enter the pressure measurement mode The following message is displayed Adjust Vess Name NEXT PED e Press Pedal to validate the name of the vessel and go to the next step The following message is displayed Occlusion PRESS NEXT PED It means that you can now adjust the value of the cuff pressure that is supposed to be equal to the occlusion pressure The next step is to press pedal to inflate the cuff The default value of the occlusion pressure is 100 mmHg It is displayed in the upper left hand corner beside the label Occl It can be adjusted turning the Q
98. ton to leave the unit configuration panel To change the configuration of the printout of the pressure From the acquisition program press the QuickButton The configuration panel is then available Select the Unit configuration with the QuickButton Press the QuickButton to validate Select Print curve on pressure with the QuickButton and press the QuickButton to validate Select 1 to print the curves with the pressure values Select 0 to print the pressure values without the curves Press the QuickButton to validate Press the Null key or select Exit and press the QuickButton to leave the unit configuration panel To change the deflation delay the following operations are to be performed The deflating delay is elapsed time between the end of the inflating after the occlusion and the start of the deflating From the acquisition screen press the QuickButton Select Unit configuration turning the QuickButton and press the QuickButton to validate Select time to deflate with the QuickButton and press again the QuickButton Adjust the deflation delay from 1 to 6 s turning the QuickButton Press QuickButton to validate Press the Null key or select Exit and press the QuickButton to leave the unit configuration panel To change the pump speed the following operations are to be performed From the acquisition screen press the QuickButton The configuration panel is then available Select the
99. two sensors on the desired locations Position the patient appropriately on his her back on the examining table You may elevate the patients head with pillows for greater comfort The patients hands should be resting comfortably on the examining table For accurate exam results the patient must be warm The room temperature should be between 22 C and 25 C The patient must remain relaxed throughout the exam Remind the patient to remain still and to refrain from talking Vasoconstricting and vasodilation agents may affect PPG signals Use of cigarettes coffee vasoactive drugs or an abnormal room temperature should be noted when performing PPG exams 01 274H 834 Atys m dical 01274H USER S MANUAL BASIC 35 Atys m dical USER S MANUAL BASIC Select two channel photo plethysmography PPG ph2 in the examination selection menu e From the acquisition screen press the QuickButton The configuration menu is displayed Turn the QuickButton counterclockwise to put the cursor on Examination if not frozen Press the QuickButton Turn the QuickButton to put the cursor on PPG ph2 Press the QuickButton The BASIC returns automatically to the acquisition screen Obtain good quality waveforms 6 2 Adjustment During the acquisition the user performs the following adjustments Selection of the arterial mode with the Filter key The selected filter must be Artery Amplitude adjustment The waveforms mu
100. tys m dical USER S MANUAL BASIC Probe holder BASIC FRONT PANEL Be A 5 le C j AN w Push button Pressure socket Infrared sensor 2 Headphone socket Basic 3 Infrared sensor 1 socket 2 channels only socket default Volume button Comment In the following the push button is renamed QuickButton 01274H A tys m dical USER S MANUAL BASIC REAR PANEL Lee es AIR FLOW ADJUSTMENT IEC PLUG FOOT SWITCH PLUG FUSES RS232 PC SOCKET CONNECTOR SWITCH ON OFF N LE SO CE Ot 0459 esate im S RS232 RATING 120VAC 1A 230VAC 500mA 50 60Hz K NI J N 01274H 16 A tys m dical USER S MANUAL BASIC 32 Mains connection At the delivery the power cord is put in the rear case The mains connection is operated by an IEC type cable delivered with the BASIC IEC 5A in 220V UL 10A in 110V This cable can be taken off the BASIC The switch beside the plug allows to switch on and to switch off the BASIC The switching on is indicated by the backlightning of the display The power cable can be placed in its transportation case and remain connected to BASIC Caution for safety it is important to check the proper state of the power cable before each setting 3 3 Probes and sensors a Venous photo 4 et 8 MHz A sensors Doppler probes tt lt a Arterial photo sensors 3 3 1 Probes At the delivery the Doppler probes are connected in the upper cas
101. uickButton The occlusion value 01 274 H 53 A tys m dical USER S MANUAL BASIC cannot be greater than 300 mmHg The occlusion pressure must be 20 to 30 mmHg higher than the systolic pressure e Press the foot pedal to inflate the cuff Beeps must be heard before starting the pressure measurement see 7 6 1 For safety the user has to press the foot pedal all along the inflation Otherwise the inflation is stopped During the inflation the following message is displayed Inflating PED The BASIC inflates the cuff up to the input occlusion pressure and then deflates the cuff automatically The deflating occurs X seconds deflation delay after the end of the inflating So during this time if the input occlusion pressure is not high enough for the occlusion it is possible to resume the inflation without deflating the cuff To do so release the Pedal and just after press again the Pedal the inflation is resumed You have to release the Pedal as soon as the occlusion is reached e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure value is displayed on the upper left hand side corner The cursor indicates the place where the pressure is calcul
102. veins appear to be competent but the superficial veins appear to be incompetent Abnormal The deep veins appear to be incompetent and the superficial veins may or may not be incompetent 01 274 H 83 A tys m dical USER S MANUAL BASIC 22 BIBLIOGRAPHY AbuRahma Ali F and Edward B Diethirch Current Noninvasive Vascular Diagnosis Littleton MA PSG Publishing Co 1988 Bandyk Dennis F MD and Brian L Thiele MD Noninvasive Assessment of Carotid Artery Disease The Western Journal of Medicine 1983 pp 486 500 Barnes Robert W MD Evaluating Peripheral Arterial Occlusive Disease Postgraduate Medicine 59 N 2 February 1976 98 103 Bernstein Eugene F MD PHD ed Noninvasive Diagnostic Techniques in Vascular Disease oe edition St Louis MO Mosby Co 1982 Breslau P J MD M G A VanSoest R Prevoo and B Jagtman Hemodynamic Parameters for Venous Value Incompetence in the Lower Extremity Netherlands Journal of Surgery 38 N 1 1986 pp 1 5 Buchbinder Dale MD and D Preston Flanigan MD Arterial Disease of the Lower Extremities Diagnosis September 1986 pp 79 90 Buchbinder Dale MD Keith Calligaro MD Carolyn Semrow and D Preston Flanigan MD Documentating Carotid Artery Disease Diagnosis May 1987 pp 83 92 Buchbinder Dale MD D Preston Flanigan MD and Carolyn Semrow Venous Disease of the Extremities Diagnosis Janua
103. y to print continuously Press again the Pedal to print the adjustment parameters and to stop the printing 01 274 H 37 A tys m dical USER S MANUAL BASIC 7 ONE CHANNEL PHOTO PLETHYSMOGRAPHY PPG PH1 The principle is the same as for two channel photo plethysmography see 6 You can use PPG ph1 one channel photo plethysmography in the arterial mode to assess the arterial blood flow supply to specific location PPG Ph1 can be used to perform digital test or to measure the strength of arterial pulsations in the tissue surrounding a wound By assessing relative circulation in the area of a wound you may be able to establish a prognosis for healing In general weaker arterial pulsations indicate poorer circulation For better visualisation you may need to increase the waveform size with the amplitude key However the more you increase the size the poorer the blood supply is to the area being examined In this test the amplitude key allows to adjust the gain The gain values are 1 2 5 10 20 50 and 125 If the gain is equal to 125 and the waveform is still weak small amplitude for most of the exam sites the tissue perfusion is very low in the case of a wound there may be little chance that the wound will heal on its own Conversely if the waveform is strong large amplitude for most of the sites examined the tissue perfusion is correct in the case of a wound there is a better chance for the lesion to heal on
104. you have just to release the Pedal and just after press again the Pedal You have to press the Pedal until the occlusion is reached In this case you have to release the Pedal to stop the inflation e After the inflation the BASIC deflates the cuff automatically The deflation occurs X seconds deflation delay after the end of the inflation So during this time if the input occlusion pressure is not high enough it is possible to resume the inflation without deflating the cuff To do so release the Pedal and just after press again the Pedal the inflation is resumed You can release the Pedal as soon as the occlusion is reached The deflation occurs X seconds deflation delay after the end of the inflation If the occlusion pressure is equal to 300 mmHg X 0 Otherwise the deflation delay can be equal to 1 to 6 s The adjustment of this delay is performed in the Unit configuration menu see 13 6 e As the pressure cuff deflates the BASIC records the returning waveform During the deflation the following message is displayed Deflating STOP PED Once the signal is returned you can press Pedal to deflate quickly the cuff e Once the cuff is deflated the screen is frozen e The systolic pressure value is displayed on the upper left hand side corner The cursor indicates the place where the pressure is calculated You can move the cursor turning the QuickButton in order to get the valu

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