ABI User Manual - Global Medical Solutions
Contents
1. biological effects may be identified in the future current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks if any that may be present Prudent Use Approved May 1999 The AIUM advocates the responsible use of diagnostic ultrasound The AIUM strongly discourages the non medical use of ultrasound for psychosocial or entertainment purposes The use of either two dimensional 2D or three dimensional 3D ultrasound to only view the fetus obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments the possibility exists that such biological effects may be identified in the future Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient Safety in Training and Research Approved March 1997 March 1983 Diagnostic ultrasound has been in use since the late 1950s There are no confirmed adverse biological effects on patients resulting from this usage Although no hazard has been identified that would preclude the prudent and conservative use of diagnostic ultrasound in education and research experience from normal diagnostic practice may or may not be relevant to extended exposure times and altered exposure conditions It is therefore cons2. to cycled in which case the display will again temporarily confirm the hold the button down approximately 3 seconds before the printer frequency of probe that is connected will respond The unit then checks for proper internal operating temperature battery voltage reference voltage and power supply voltage levels If any of these characteristics are out of range the display will show the ERROR icon and a failure code associated with the diagnostic error Diagnostic functions are periodically checked while the unit is on to ensure the Doppler is operating at peak performance Refer to the table below for failure codes Diagnostic Codes Contact Summit Service 1 Temperature too low 5 5 Volt Supply too low 2 Temperature too high 6 5 Volt Supply too high Loading Paper 3 Reference Voltage too low 7 Battery Voltage too low 4 Reference Voltage too high 8 Battery Voltage too high Warning Install the paper roll in the printer so the external side heat Coo SY Printer miscommunication sensitive side of the rolled paper is against the print head down Warning Do not use printer paper other than the type specified and supplied by Summit Doppler Other paper types could result in damage or degraded print quality and may void the warranty The printer will perform a self test print by turning the printer on while the feed button is being held down A checkered test pattern will print in addition to th
3. B 5 MHz Bi Dir X X Operation and Installation SPEAKER GRILL as af ONOFF BUTTON ___ PROBE Aa CONNECTOR HEADPHONE CONNECTOR PRINTER CONNECTOR PRINT BUTTON Side Panel Controls MODEL SERIAL NUMBER LABEL VOLUME SLIDER BATTERY DOOR Trouble shooting Warning Use alternate equipment in case of unit failure Call Summit Doppler Systems Service Department if the probe or main unit malfunctions Warning Do not drop or mishandle the LifeDop probes or accessories Damage to sensitive electrical components speakers cables transducers or plastic likely to occur Poor sound quality Inadequate gel use Try and relocate the probe for a better signal Improper choice of probe Frequency Interference from other equipment Probe coiled cable or battery contacts may be intermittent Debris in the speaker may cause poor sound Device damage from dropping the LifeDop probes or accessories Battery indicator flashing Error 5 or Error 7 Consult Diagnostic Monitoring replace batteries as described in Replacing Batteries Probe frequency does not match the connected probe Check probe that is attached to ensure it is the correct one or no probe attached If correct probe contact Summit Service Radio Frequency Interference The LifeDop was tested for immunity to electromagnetic interference at a level of 3V meter Interference during normal operation may occur in the presence of fi
4. Doppler Systems for further clarification In order to preserve protect and improve the quality of the environment protect human health and utilize natural resources prudently and rationally do not dispose of waste electrical or electronic equipment WEEE as unsorted municipal waste Contact local WEEE disposal sites or Summit Doppler Systems to dispose or equipment Safety of Ultrasound The Summit Doppler was designed with physician and patient safety in mind In early design phases all potential hazards were eliminated or reduced to As Low As Reasonably Achievable ALARA by adhering to good design practices and industry wide safety standards Ultrasound procedures should be performed with the ALARA principle in mind when delivering ultrasound energy into the body The following official statements from the American Institute of Ultrasound Medicine AIUM are provided for your general information regarding the safe use of ultrasound Clinical Safety Approved March 1997 October 1982 Diagnostic ultrasound has been in use since the late 1950s Given its known benefits and recognized efficacy for medical diagnosis including use during human pregnancy the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use There are no confirmed biological effects on patients or instrument operators caused by exposures from present diagnostic ultrasound instruments Although the possibility exists that such
5. Printer 100 4 minute exams 500 prints AA Alkaline 1 5V x3 Lithium Ion 3 7V 245 Hz 4 KHz 0 33 W 3 5 mm stereo plug Tip toward Ring away Shaft common Note Common is not a ground connection Thermal 58mm wide 33mm diameter 35mm sec 8 seconds for standard printout 48mm wide 8 dots mm 384 dots line 1 5 meter on linoleum floor RS232 8 data bits 1 stop bit no parity 115 2Kbaud Input 100 120VAC 29VA 50 60Hz Output 5VDC 2 3A center positive Auto scaled to max 4KHz 2KHz and 1KHz 25mm sec 100 mm length w 4 sec of data 175 mm total with header A Attention Consult Accompanying Documents Additional technical information is available upon customer request 17 Printer Not Printing Error 9 The LifeDop and printer have lost communication This may be due to a printer jam paper empty low printer battery or any of the above printer error codes To clear the error lift the paper cover lever reseat the paper roll and close the cover If printer communication is re established the LifeDop will automatically print the buffered waveform If Error 9 persists turn off both printer and LifeDop and re start waveform buffer Waveform appears to be the same above and below the base line This anomaly normally occurs when the probe is close to perpendicular to the vessel Reacquire the Doppler signal with the probe angle at 45 degrees as described in Obtaining Doppler Signals Faint signal is audible but
6. ain as described below The LifeDop Doppler requires very little maintenance However it is important to continuing function of the unit and the health of the patients that the unit is cleaned and examined regularly per the following guideline After every examination Excess gel should be wiped off prior to docking the probe Probes and main unit should be cleaned with a damp warm water cloth or presaturated isopropyl alcohol wipes or spray such as Transeptic from Parker Laboratories Inc In particular pay close attention to clean the seams along the plastic lines at the probe face but do not allow water or spray to enter through the connectors or speaker grill To disinfect unit use commercially available spray or wipe disinfectants registered with the EPA such as Precise QTB from Caltech Industries Inc Follow the manufacturers instructions and wipe unit until it is dry of solutions Examiners should wash hands and change gloves after every exam Refer to local and hospital policies for cleaning and disinfection policies Store unit in a clean area free from dust and debris Follow temperature and humidity guidelines as specified at the end of this manual Warning If the unit is to be stored for longer than 90 days without use remove the batteries prior to storage Periodically at least annually Inspect the main unit and probes for signs of cracks or breaks in the mechanical housing Inspect cables and connectors for s
7. and waits until the printer is ready to print out a record of the examination LCD Display The LCD display allows you to view information in large easy to read digits including probe ID battery life signal strength indicators and multiple diagnostic indicators that ensure your unit is functioning at peak performance levels SSQ Superior Sound Quality LifeDop ABI is designed with a state of the art sound system that produces excellent sound quality and long term reliability Main Unit Feature Catalog SSQ Display _Download L250ABI X X X Probe Summit Doppler ultrasound transducers were designed to meet your specific application need Each probe has been ergonomically designed for comfort while providing excellent maneuverability for locating the vascular target Every probe is carefully measured and tested to ensure it meets exacting performance standards 8 MHz Directional Probe This standard pencil style probe is an excellent vascular tool for locating specific shallow vessels in the peripheral vascular system The narrow grip and small face of the probe make it ideal for maneuvering for maximizing the signal in both flow directions 5 MHz Directional Probe This pencil style probe with wide beam and deep penetration is designed for locating deep vessels in the peripheral vascular system The narrow grip is easy to maneuver Probe Application Catalog PV ABI PV General SD8B 8 amp 8 MHz Bi Dir X X SD5
8. cts are loaded first and then press the battery firmly into place Warning If the batteries have been inserted incorrectly the unit will not function but the LifeDop will not be damaged Recharging Printer Batteries Warning Use only the battery and AC adapter supplied with the printer Use of any other battery and or AC adapter is hazardous and may cause damage to the equipment Warning Do not connect the printer to the Doppler while the printer is charging Turn the printer off Lift the C rubber flap on the left side of the a printer and plug in the connector S of the recharge adaptor Make sure recharger is plugged into a standard 120VAC outlet When properly connected the LED will be red Upon completion of charging the LED will be green Printer Recharger Remove the recharger and replace the rubber flap 14 HEART RATE INDICATOR ev SATE ce OTE ce INDICATOR INDICATOR ERROR INDICATOR PLAY INDICATOR an NOT USED DISPLAY AREA INDICATOR IGNAL QUALITY NOT USED INDICATOR LCD Display Status indicator Power switch l Feed switch AC adapter connection Cover open lever When replacing forms DIP switch operation NOT USED v A SANW RS 232C connection TT N Battery mounting IrDA light receiving NOT USED e A od e la e la hs E A comprehensive In Service Training Video is now available Turning Unit O
9. dx VASCULAR SYSTEM ABI User Manual opler SummitD Listening to Life Thank you for choosing Summit Doppler Systems We believe you have purchased the finest handheld Doppler and portable printer on the market Your total satisfaction is our highest priority as we strive to continually improve our products and services Please contact us with any suggestions We look forward to enjoying a long term relationship with you Summit Doppler Systems Inc 4680 Table Mountain Dr 150 Golden CO 80403 Here s how you can reach us Phone 1 800 554 5090 303 423 7572 Fax 303 940 7165 e mail us at sales SummitDoppler com Visit our website at www SummitDoppler com Table of Contents Page Intended use Contraindications Warnings 3 Description of product table of features 4 Operation and Installation cccceeee eee 5 Obtaining Doppler Signals 00ee eee 8 Printer Oper ann s cnscctessectcscissdetatacectgrsctasie 8 Diagnostic Monitoring ccc cece cece cece ees 12 PROCS GS OUIC Gi jatar ciamecens te nancsdasdeetaeccetsemsasecuet 12 Mamtenance Cleanine sis5 00s2ccd ssoashacanedoeseaxt 13 Replacing Recharging Batteries 000 14 Clinical RETCtCHCES e aserria iaa orara 16 Sle CMC AN OMS sre ea e EREA 17 Trouble Shoo errereen kaner ENESENN 18 W a E EE 19 Please read the manual carefully and become familiar with the operation
10. e are no user controls which affect the T ultrasound output Summit Doppler Systems Inc provides general reimbursement information related to the diagnosis of peripheral arterial disease as an overview for our customers Itis important to understand that reimbursement is a complex process and requirements are subject to change without notice It is the responsibility of the healthcare provider to determine and submit appropriate codes charges and modifiers for services that are rendered Prior to filing any claims customers are advised to contact their third party payers for specific coverage coding and payment information Summit Doppler Systems Inc makes no promise or guarantee of reimbursement by Medicare or any other third party payer Intended Use This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease Federal law restricts this device to sale by or on the order of a licensed practitioner Contraindications Warning The vascular probes are not for fetal use Warning The ultrasound probes are not to be used on or near the eyes Warning The device is for use only on intact skin Warning Do not plug any part of this device into a telephone or modem Warning This device is not intended for use with HF surgical equipment If there are questions or concerns regarding these warnings or contraindications please do not hesitate to contact Summit
11. e printer configuration and loaded fonts Accessories Contact Summit Service at 1 800 554 5090 or 303 423 7572 to order by phone or order on line on our website www SummitDoppler com Description Part Number Description Part Number Alkaline battery BATO002 Coiled Cable CBLOOO1 Lithium Ion battery BATO004 Printer Cable CBLOO11 Carry Case PKG0003 Gel 60 gm GEL0001 User Manual MANOO007 Gel 250 gm GELO002 Quick Reference Guide MANOO08 Printer Paper Labels MMH0014 ABI Assessment Form MKT0042 Printer Paper 10 yr MMH0015 ABI In Service Video MKT0076 12 Printer Connections Printing a Waveform Warning The print head becomes hot during printing Do not touch the print head after printing Warning Turn off the printer and check that the head is fully cooled before attempting to fix a paper jam replacing paper or removing the print roller for any reason Once the printer is operational and the cables are in place the LifeDop will automatically download the waveform and printing will begin If the PRINT button is pressed while the printer is connected and ready printing will start immediately Waveforms are automatically scaled to a maximum frequency of either 1 KHz 2 KHz or 4 KHz for optimal waveform height Markings on the vertical axis are provided every KHz Printer calibration is not required iis 2KH2 4KHz 0 0 0 1KHz 2KHz 4KHz Auto Scaling 1 kHz 2 kHz and 4 kHz Di ak uh k E x i E Fatien
12. e sound The steeper the probe angle the higher the frequency of the sound Signal Quality Indicator Once flow sounds are found the signal strength indicators give the user a visual display of the flow direction and relative strength of the signal Four bars of the left indicate flow toward the probe while the four bars to the right indicate flow away from the probe Vary the probe position and angle as described above while viewing the indicators to obtain the best results Buffering a Waveform Once the desired flow is found press the red PRINT button on the side of the unit to buffer the PREVIOUS four seconds of flow When the waveform is buffered as indicated by STR on the display the probe is temporarily shut off and can be removed from the patient The printer need not be connected to buffer the waveform the LifeDop waits until the printer is ready Note Only one waveform can be buffered at a time and the LifeDop must remain ON in order to retain the waveform 8 Maintenance and Cleaning Warning The LifeDop is not designed for liquid immersion Do not soak or drop the Doppler main unit or probes in liquids Use only spray or wipe cleaners and disinfectants Warning The LifeDop is not designed for sterilization processes such as autoclaving or gamma radiation Warning The LifeDop is not intended to be used on open skin If there is evidence of open wound contamination disinfect the probe before using ag
13. elds stronger than 3V meter If this occurs try to increase the distance between the LifeDop and the source of interference Contact Summit Doppler for more information Printer LED Red or Orange Green Orange Red Error Solution LED LED LED Flash2x No Error Normal P lash Low Battery Recharge pd Flash ix Outof Paper _ Reload Paper _ lash 2x Open Cover _ Close Cover _ lash 3x Thermal Failure Call Summit _ Plash4x Voltage Failure Call Summit Printer DIP switches are preset at the factory The printer will not function properly if they are moved from these set positions 15 Replacing LifeDop Batteries Warning Replace batteries only with batteries supplied by Summit Doppler Systems The battery compartment only accepts AA size batteries See accessories list for part number and re order information Open the battery compartment by depressing the tab and pulling outward on the battery door Remove the existing drained batteries by pushing on the end of the battery that compresses the battery contact spring and lift upwards Itis acceptable to use a small tool or pen to assist in this step Replace the batteries by paying close attention to the polarity indicators on the battery and the polarity indicators on the battery holder in the compartment Positive aligns with positive button and negative aligns with negative spring Insert the battery such that the spring conta
14. es to the device that occur as a result of the inadequate shipping to Summit Doppler Systems improper maintenance or cleaning as described in the user manual misuse abuse alteration of the equipment from it s original specifications or dismantling the unit other than by Summit Doppler Systems approved service technicians Service Returns To return products to Summit Doppler 1 Call Summit Doppler Systems to obtain a Return Authorization and to receive any final instructions prior to shipping 2 Clean the product prior to shipping 3 Ensure the device is well packaged and suitable for shipment Send the product to Service Department Summit Doppler Systems Inc 4680 Table Mountain Dr 150 Golden CO 80403 For customer service technical service cleaning maintenance or shipping questions please call 303 423 7572 or 1 800 554 5090 19 Transducer Model LifeDop 5 MHz Bi DirOperating Mode Continuous Wave cw Application s Peripheral Vascular Global Maximum Value gt Global Maximum Value gt Value Associated Acoustic cm X Parameter Beam Dimensions Transducer Model _LifeDop 8 MHz Bi Dir EET Mode Continuous Wave cw Application s Peripheral Vascular Global Maximum Value S Maximum Global Maximum Value S me Mp 7 mW Associated M Acoustic a cm Parameter Beam Dimensions EBD Ispra3 the derated spatial peak temporal average intensity mwatts per cm Isppa3 the de
15. features and maintenance of your Doppler prior to using the device or accessories Authorized Representative BellyTalk BV Benedictijnenstr 8 47 1566LB Assendelft Holland Manual Part Number MAN0007 Rev G Warranty and Servicing Policy Summit Doppler Systems Inc is pleased to present our customers with a 30 day no hassle evaluation return policy in the event that you are not satisfied with our product The warranty on this product is that it will be free from defects in material and workmanship for 12 months from the original sale of the device This includes all parts and labor required to repair or replace the unit to original specifications and shipping costs associated with sending the product back to the customer Customer is responsible for providing adequate packaging materials and shipping costs to Summit Doppler Systems Products shall be repaired or replaced in a reasonable amount of time Summit Doppler Systems liability for any claim is limited to materials and labor associated with repair or replacement In no event shall Summit Doppler Systems be liable for incidental or consequential losses or damages in connection with the purchase of this product Summit Doppler Systems disclaims all express or implied warranties agreements or arrangements other than issued in this warranty unless specified in writing and signed by the President of Summit Doppler Systems Summit Doppler Systems is not responsible for damag
16. idered appropriate to make the following recommendation In those special situations in which examinations are to be carried out for purposes other than direct medical benefit to the individual being examined the subject should be informed of the anticipated exposure conditions and of how these compare with conditions for normal diagnostic practice 4 Specifications Degree of protection against electric shock Type B Applied part O Class 1 Equipment Degree of protection against ingress of water IPX4 extending 2 5 cm from tip IPX1 entire probe 2 5 cm from tip excluding connector Designed and tested to meet IEC601 1 IEC60601 1 2 IEC60601 1 4 IEC60601 2 37 EN5011 A Connect the LifeDop only to equipment that meets the appropriate standards Dimensions h w 1 Weight Operating temperature Operating humidity Transport Storage temp Transport Storage humidity LifeDop Printer 140x70x35 mm 136x84x43 mm 320 grams 280 grams 10 to 40 C 0 to 40 C 30 to 75 20 to 85 20 to 50 C 20 to 60 C 5 to 90 non condensing for both units beyond 30 days battery to be stored between 20 and 30 C Battery life Battery voltage type Audio bandwidth and power Audio cable pin out Printer Paper Type Size max Printer Speed Printer Resolution Printer Impact Resistance Printer Communication Printer Recharger Waveform Frequency Scale Waveform Time Scale Printout Length LifeDop
17. igns of wear or failure The user should discontinue use of the unit with any sign of loss of housing integrity Contact Summit Doppler Systems for service It is recommended that rechargeable batteries be replaced annually 13 Diagnostic Monitoring Connecting the Printer Ensure that the printer is loaded with paper and connect the cable to the All LifeDop Doppler units perform continuous diagnostic monitoring and give printer and LifeDop as shown with connector tabs down as labeled THIS a visual indication of battery level The LifeDop uses a multiple level battery SIDE UP Turn the printer on by HOLDING the power button down shaped icon that indicates the voltage level of the battery The battery outline approx 3 seconds until the LED comes on If the printer is functioning will flash when the battery level is very low indicating that the user should properly and ready to print the LED will flash green twice every second change the batteries soon after the current examination is complete i i j Warning Forcing the cable upside down will cause damage to the connector Once the unit is on the LifeDop performs a series of diagnostic checks The pins on the LifeDop cable and printer Note label THIS SIDE UP unit first checks and displays the frequency of the probe that is being used This display will not change unless the probe is changed or the power is Note When turning the printer on or off it is important to remember
18. n Off Turn the LifeDop on by pressing the On Off button LCD indicators show power status The LifeDop automatically shuts itself off after 5 minutes if it is not being used Turn the Printer on by pressing and holding the On Off button until the green LED comes on approximately 3 seconds Printer automatically shuts itself off after 30 minutes Volume Slider The audio level can be adjusted using the Volume Slider Moving the slider up will increase the volume while moving it down will decrease it The volume slider does not affect the headphone output Obtaining Doppler Signals and Printer Operation Caution Doppler examinations should be performed only by trained individuals For any Doppler examination it is essential that an adequate supply of coupling gel be used to transmit the ultrasound energy from the probe to the surface of the skin Re apply more gel if it starts to dry out or spread so thinly that an air gap occurs between the probe and the skin It is not necessary to cover the entire surface of the probe only the probe face Applying too much gel makes the unit difficult to clean and does not aid in the performance of the probe For the best results angle the probe approximately 45 degrees from the skin surface over the general location of the vessel Slowly move the probe side to side and vary the angle of the probe until the vascular sounds are heard Changing the angle of the probe has an affect on the frequency of th
19. rated spatial peak pulse average intensity watts per cm MI the Mechanical Index P 3 the peak rarefactional pressure megapascals associated with the transmit pattern giving rise to the value reported for MI Wi the total time average ultrasonic power mwatts fe the probe center frequency MHz Zsp the axial distance at which the reported parameter is measured cm X6 Y 6 are the 6dB beam dim in the x y plane where z is found cm EBD the entrance beam dimensions cm These dimensions are the same as the dimensions of the transmit crystal Measurement Uncertainties Power 34 42 Pressure 11 16 Intensity Ispta 23 26 Frequency 5 Acoustic Output Parameters are measured in water Derated values denoted by the subscript 3 take into account a conservative level of attenuation that would be encountered in the human body The derated intensity values I3 are obtained from water values of intensity Iw at a depth of z calculated by 1 exp 0 23 0 3 f z 1 where f is the probe frequency in MHz and z is the depth in centimeters The derated peak rarefactional pressure is calculated from the value of measure water pr by P 3 exp 0 115 0 3 f z p where pressure is given in megapascals Additional Output Reporting Information for IEC 61157 8 MHz I lt 112 mW cm Note that parameter Z in the probe reporting tables is the same parameter as I in IEC 61157 Operating Conditions Ther
20. t Hame Patient ID Date Time Notem Printout Blood flow in the direction toward the probe is shown above the baseline Flow away from the probe is shown below the baseline These two traces are provided so that flow in both directions can be displayed simultaneously 10 Report Generation Report generation is made very simple with adhesive backed printer paper provided by Summit Doppler eliminating the need to cut and tape the strip of paper The label paper backing is precut down the center fold the paper down the middle and peal from the center Attach the waveform to the pre printed ABI assessment Form Ankle Brachial Index Risk Assessment Form Patient Name SS _ ABI Severity of Disease 0 90 1 30 WNormal 0 70 0 89 Mild 0 40 0 69 Moderate 0 00 0 39 Severe SummitD popler www SummitDoppler com Listening to Life 1 800 554 5090 ABI Assessment Form 1
21. waveform is not obtained on printout The LifeDop main unit is designed to reject noise and certain artifacts Even a valid signal must reach a threshold before it can be printed therefore it is normal for some very weak signals to be rejected Printer Switches not set in proper location The printer switches have been preset at the factory to the proper location however if they have been changed the printer will not function Orient the printer and set the DIP switches to match the following 1 Up 2 Down 3 Down 4 Down Reference materials for Peripheral Vascular testing Noninvasive Diag of Peripheral Vascular Disease W Robert Felix Jr 1988 Current Noninvasive Vascular Diagnosis Ali F Aburahma Edward B Diethrich 1988 Vascular Disease Foundation www vdf org American Heart Association www americanheart org American Diabetes Association www diabetes org 16 Description of product The Summit LifeDop ABI is factory configured to include many features and product enhancements Along with interchangeable ultrasound transducers the Summit Doppler device is well suited to meet your specific needs Main Unit The main handheld unit is ergonomically designed to fit the palm of your hand with comfort and allow easy access to each control feature Each unit is individually tested and inspected to ensure the highest quality standards Printer Download The LifeDop buffers 4 seconds of waveform data
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