ABI User Manual - Global Medical Solutions
Contents
1. 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 the unit use commercially available spray or wipe disinfectants registered with the EPA such as Precise QTB from Caltech Industries Inc Follow the manufacturer s 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 Caution If the unit is to be stored for longer than 90 days without use remove the batteries prior to storage 18 Volume Loading Paper Caution Install the paper roll in the printer so the external side heat sensitive side of the rolled paper is against the print head do2. standard 120VAC outlet When properly connected the LED will be red Upon gt completion of charging the LED will turn off Remove the recharger and replace the rubber flap Printer Recharger Accessories Contact Summit Doppler Systems Service Department at 1 800 554 5090 or 303 423 7572 to order by phone Description Part Number Alkaline battery BAT0002 Lithium lon battery BAT0O006 Coiled Cable CBL0001 Printer Cable CBL0030 Carry Case PKG0006 User Manual MANO026 Gel 60 gm GELOO01 Gel 250 gm GEL0002 Printer Paper Labels MMH0014 Printer Paper 10 yr MMH0015 ABI Assessment Form MKT0180 ABI In Service Video MKT0076 20 Product Description The LifeDop 300ABI is a full featured handheld Doppler designed to serve the needs of clinicians performing the ankle brachial index ABI exam Limb systolic pressures are obtained with a highly sensitive bi directional ultrasound Doppler probe Each limb pressure can be stored for calculation of the left and right ABI s Doppler waveforms can be stored for each ankle Examination results are printed on a high speed battery powered portable printer Main Unit and Doppler Probes The L300ABI main unit is a handheld Doppler with keypad for calculation of the ABI results This battery powered unit is designed to provide the best possible detection of arterial blood flow The L3QQABI uses bi directional probes with 8 MHz standard or 5 MHz optional operating frequency B
3. 384 dots line Printer Impact Resistance 1 5 meter on linoleum floor Printer Communication RS232 115 2K 8 1 no parity Printer Recharger Input 100 120VAC 29VA 50 60Hz Output 5VDC 2 3A center positive Waveform Frequency Scale Auto scaled to 4KHz 2KHz and 1KHz Waveform Time Scale 25mm sec 100 mm w 4 sec of data Printout Length 38 mm total with header A Attention Consult Accompanying Documents Additional technical information is available upon customer request 23 Printer LED Red or Orange Green Orange Red LED LED LED Flash2x No Error Normal ne Flash Low Battery Recharge Flashix ______ Outof Paper Reload Paper __ Flash2x Open Cover____ Close Cover Flash3x Thermal Failure Call Summit T Voltage Failure Call Summit 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 Faint Signal is Audible but Waveform is not Visible 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 print
4. THIS SIDE UP Turn the printer on by HOLDING the power button down approximately 3 seconds until the LED comes on If the printer is functioning properly and ready to print the LED will flash green twice every second a A a Printer Connections To disconnect the printer cable from the LifeDop press the tabs on the edges of the connector On the printer end the latching tab is on the back of the connector Caution Forcing the cable upside down will cause damage to the connector pins on the LifeDop cable and printer Note the label THIS SIDE UP Note When turning the printer on or off it is important to remember to hold the button down approximately 3 seconds before the printer will respond 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 signs 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 at 800 545 5090 USA or 303 423 7572 Outside of USA It is recommended that the printer s rechargeable batteries be replaced annually Replacing LifeDop Batteries Caution 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 Caution Be sure to follo
5. the operation features and maintenance of your Doppler prior to using the device or accessories Manual Part Number MAN0O026 Rev A Summit Doppler Systems Inc provides general reimbursement information related to the diagnosis of peripheral arterial disease as an overview for our customers It is 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 This device is not intended for use with HF surgical equipment General Warnings Warning The LifeDop 300ABI is for use by qualified personnel only Read the User Manual before use W
6. AHA 2001 2 Techniques in Noninvasive Vascular Diagnosis an Encyclopedia of Vascular Testing Daigle RJ Summer Publishing 2002 137 148 3 Olin JW Clinical Evaluation and Office Based Detection of Peripheral Arterial Disease contained in Primary Care Series Peripheral Arterial Disease and Intermittent Claudication Hirsch AT Ed Excerpta Medica Inc 2001 4 ACC AHA Guidelines for Management of Patients with Peripheral Arterial Disease 2005 17 The Doppler 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 1 KHz Printer calibration is not required 2KHz 4KHz 1KHz 1KHz KHz ARNE Auto Scaling 1 kHz 2 kHz and 4 kHz Blood flow in the direction toward the probe is shown above the baseline Flow away from the probe is shown below the baseline Two traces are provided so that flow in both directions can be displayed simultaneously Sample Doppler Waveforms Normal Ankle Waveforms Triphasic xx RIGHT ANKLE WAVEFORM O u uJ a Lu ac lt L Ke uw lu The waveforms are pulsatile with forward and reverse flow 16 Flow Direction Bar Graphs The flow direction bar graph provides a visual aid for acquiring the Doppler waveform The number of segments that are displayed is proportional to the velocity of the blood flow The arrows pointing to the le
7. Summit Doppler Systems Inc 4680 Table Mountain Dr 150 Golden CO 80403 303 423 7572 800 554 5090 www SsummitDoppler com ABI VASCULAR SYSTEM TELE LEE ECEE User Manual SummitDeppler Listening to Life Warranty 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 This product is warranted to be free from defects in materials 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 damages to the device tha
8. and Left Brachial Pressure L BRA There also two ABI sites L and R See also Site Location Indicator below Print Press the PRINT key to print all stored data Printing will begin immediately if the printer is enabled and connected If the printer is not on line the display will show Prn and printing will commence as soon as the printer is on line aL p h 7 x 5 ABI Pressure Data ABI Pun am BRA BRA Site Locations ei WAV WAV Battery Indicator aaa eee Flow Direction Keypad Numerals 0 9 Enter each limb s systolic pressure data using the numeric keypad The pressure is stored in the site location shown on the display Once the pressure is entered the unit automatically advances to the next site location Clear Below Numeral 0 Pressing the clear button erases the pressure or waveform stored in the currently selected SITE location Site Location Indicator When flashing the site location indicator denotes that the current site location does not contain data The current site location stays on to denote that data has already been stored in that location Abnormal Ankle Waveforms Monophasic 4h RIGHT ANKLE WAVEFORM ra ao Li hal m but car a t UL Liu l These waveforms have no reverse flow component and minimal pulsatility References for the ABI Exam 1 Human Blood Pressure Determination by Sohygmomanometery American Heart Association
9. arning Carefully route all cables and tubing to reduce the possibility of patient entanglement or strangulation Warning Do not plug any part of this device into a telephone or modem Warning Do not use equipment that is damaged or malfunctioning Seek appropriate service when needed Inspect equipment regularly for signs of damage Use alternate equipment if needed Specifications Degree of protection against electric shock R Type B Applied part 0 Class II 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 LifeDop Printer Dimensions h w 1 147x70x35 mm 136x84x43 mm Weight 320 grams 280 grams Operating temperature 10 to 30 C 0to30C Operating humidity 30 to 75 20 to 85 Transport Storage temp 20 to 50 C 20 to 60 C Transport Storage humidity 5 to 90 non condensing for both units beyond 30 days battery to be stored between 20 and 30 C LifeDop Printer Battery life 40 12 minute exams 500 prints AA Alkaline 1 5V x3 Lithium lon 3 7V Audio bandwidth and power 245 Hz 4 KHz 0 33 W Printer Paper Type Size max Thermal 58mm wide 33mm diameter Printer Speed 35mm sec 8 sec for standard printout Printer Resolution 48mm wide 8 dots mm
10. data into three sections at the indicated markings Peel the back from each section of label paper and stick the pressures and two waveform strips Right Brachial Artery Pressure 8 Connect the hose from the hand pump to the cuff on the right arm Apply a small amount of gel over the patient s brachial artery on the right arm and place the Doppler probe at approximately 45 degrees pointing in the direction toward the shoulder as shown in Figure 3 Slide the probe laterally across the arm to find the brachial artery and obtain the best signal possible Figure 3 9 Find a stable and comfortable position to brace the probe hand while quickly inflating the cuff 20 mmHg above the occlusion pressure at this point Doppler sounds are no longer heard Be sure that the Doppler probe stays on the artery during inflation 10 Deflate the cuff at approximately 2 mmHg per second by gently squeezing the pressure release trigger on the aneroid Listen for the blood flow sounds to return When the flow sounds return this is the systolic pressure Once this pressure is obtained rapidly deflate the remaining pressure in the cuff 11 Use the LifeDop s keypad to enter the pressure for the R BRA site The site will automatically advance to the R ANK location after the brachial pressure is stored 1 Right Ankle Waveform 12 Acquire a Doppler signal at either the posterior tibial PT or dorsalis 13 12 pedis DP artery as
11. e pressure when flow returns then rapidly deflate the cuff Use the LifeDop s keypad to enter this pressure in the R ANK site The site location will automatically advance to the L WAV location NOTE Some protocols call for obtaining pressures from both the DP and PT arteries and using the higher of the two pressures in the calculation of the ABI In this case obtain both pressures and then enter the higher of the two in the R ANK location Completing the Exam for the Left Side 17 Obtain the Doppler waveform from the patient s left ankle DP or PT artery and use the red button to store in the L WAV location Left DP Left PT 13
12. ed therefore it is normal for some very weak signals to be rejected Verification of Printer Switch Setttings Caution Printer DIP switches are preset at the factory The printer will not function properly if they are moved from these set position 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 22 Warning Do not connect Luer fittings from Summit Doppler equipment into any other equipment If there are questions or concerns regarding these warnings or contraindications please do not hesitate to contact Summit 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 of equipment Safety of Ultrasound The Summit Doppler LifeDop 300 ABI System 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 perform
13. ed 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 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 effec
14. ervices Please contact us with any suggestions We look forward to enjoying a long term relationship Associated Acoustic Parameter Application s Peripheral Vascular Transducer Model LifeDop 5 MHz Bi Dir Operating Mode Continuous Wave cw Application s Peripheral Vascular Associated _ oN yi Acoustic Parameter xe em f 0 42 0 14 Ispra 3 the derated spatial peak temporal average intensity mwatts per cm Isppa3 the derated 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 W the total time average ultrasonic power mwatts f 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 13 are obtained from water values of intensity Iw at a depth of z calc
15. ft indicate flow going toward the probe tip The arrows pointing to the right indicate flow going away from the tip Battery Icon When flashing the battery icon indicates that the LifeDop s batteries are low and should be replaced Store Waveform Press the red button on the side of the LifeDop 300ABI to store Doppler waveforms in either the Left Ankle L ANK or Right Ankle R ANK site locations The display will show Str to indicated that an ANK site contains stored data Probe Connector Plug the probe cable into the top connector on the side panel Headphone Connector Connect headphone 32 ohm Flow coming toward the probe is heard in the left side flow going away from the probe is heard in the right side Performing the Ankle Brachial Index ABI Examination The ABI for each leg is determined by dividing the ankle pressure by the higher of the two arm pressures Doppler waveforms from the ankles aid in the diagnosis of PAD and are usually required for reimbursement NOTE To avoid losing data during the exam do not turn the LifeDop off until the results are printed Replace batteries LifeDop or recharge Printer before beginning the exam if needed 1 Inawarm room have the patient take off shoes and socks and rest in a Supine position for approximately 5 minutes prior to taking pressures Patient should wear thin loose fitting clothing Avoid rolling up sleeves or pant cuffs in such a manner that it obstructs bl
16. i directionality is the ability to discriminate arterial flow towards and away from the probe which is essential for proper display of the ankle waveforms The 8 MHz probe is optimal for measuring the systolic blood pressure in the extremities for most patients For larger patients an optional 5 MHz probe is available The 5 MHz probe offers deeper penetration and a slightly wider beam but is actually less sensitive on shallow vessels than the 8 MHz probe The L300ABI is powered by three AA alkaline batteries and is provided with a user replaceable probe cable Probe Catalog Description ABI Shallow __ Deep SD8B 8MHz Bi Dir X X SD5B 5MHz Bi Dir X X Portable Companion Printer Exam results are printed on a high speed battery powered printer This printer uses thermally sensitive paper Our standard paper is adhesive backed label paper Label paper makes 8 5 x 11 inch report generation fast and easy The printer is powered by a lithium ion rechargeable battery and comes with its own recharger Installation and Basic Operation Preparing the Equipment for Use Recharge the printer before use Plug the probe cable into the main unit and become familiar with the equipment s capabilities and limitations by reading the LifeDop and Printer User Manuals prior to use Connecting the Printer Ensure that the printer is loaded with paper and connect the cable to the LifeDop and printer as shown with connector tabs down as labeled
17. ikely 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 on LifeDop Replace batteries as described above 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 fields 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 Self Test The printer will perform a self test by turning the printer on while the feed button is being held down A checkered test pattern will print in addition to the printer configuration and loaded fonts 21 Recharging Printer Batteries Caution 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 rubber flap on the left side of the printer and plug in 7 the connector of the recharge adaptor Make sure recharger is plugged into a
18. ood flow Bulky items such as sweaters should be removed 2 Wrap the cuffs snuggly around the arms and ankles as shown in Figures 1 and 2 The edge of the cuff should be placed approximately 1 to 2 inches above the site of examination Select the proper cuff width equivalent to 40 of the patient s limb circumference In general average sized adults use 10 cm cuffs while larger adults use 12 cm cuffs Figure 1 Figure 2 While applying the cuffs it may be a good time to explain the examination to the patient and answer any questions they may have during this period 10 Interpreting the Examination Results Ankle Brachial Index The ankle brachial index ABI is determined by dividing the ankle pressure by the higher of the two brachial pressures A separate ABI is determined for each leg These calculations are done automatically by the LifeDop 300ABI ABI ankle pressure higher brachial pressure For example Right brachial 120 mmHg Left brachial 126 mmHg Right ankle 145 mmHg Left ankle 92 mmHg Right ABI 145 1 15 126 Left ABI 92 0 73 126 An ABI less than 0 9 is considered abnormal The following interpretation levels are based on the 2005 AHA ACC PAD Guidelines ABI Interpretation levels Noncompressible 1 00 1 29 Normal 0 91 0 99 Borderline 0 41 0 90 Mild to moderate PAD 0 00 0 40 Severe PAD Doppler Waveforms Waveforms are interpreted by examining
19. shown below Start by applying a small amount of gel to the site and tilt the probe at a 45 degree angle pointing the probe tip toward the calf and knee Slide the probe across the general location of the artery until the best signal is obtained Normal patients will usually have tri phasic or bi phasic ankle waveforms Patients with peripheral arterial disease PAD will have reduced flow which results in a waveform with fewer changes in flow direction Often with these patients the signal will be mono phasic meaning the flow is always in one direction Right DP Right PT Maintain the best signal possible for a minimum of 4 seconds and press the red button on the side of the LifeDop to store the waveform in the R WAV location The site location will show Str and then automatically advance to R ANK Storing the Right Waveform Right Ankle Pressure 14 Connect the cuff hose to the right ankle cuff Use either the PT or 16 DP artery to obtain the ankle systolic pressure Acquire the Doppler signal Brace your probe hand while inflating the cuff to a pressure 20 mmHg above the occlusion pressure which is the point at which flow sounds are no longer heard Be sure to keep the probe on the artery while inflating Deflate the cuff at 2 mmHg sec by gently squeezing the pressure release trigger on the aneroid Be sure not to move the probe Listen for the blood flow sounds to return this is the systolic pressure Note th
20. t 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 its 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 4 Include a note in the package with your contact information including Name Phone Number and Return Address as well as a description of the problem 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 8303 423 7572 or 1 800 554 5090 25 Application s Peripheral Vascular Transducer Model LifeDop 8 MHz Bi Dir Operating Mode Continuous Wave cw Ispra Isppag ACOUSTIC OUTPUT mWicm Wiem Global Maximum Value gt e ae O ISS Value 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 s
21. the combination of rise time fall time presence of reverse flow components and height Normal waveforms have relatively fast rise and fall times and are multiphasic i e one or more reverse flow components With PAD the rise and fall times are lengthened the reverse flow components are lost and the height is diminished 15 4 Move the hose to the left ankle cuff Take the left ankle pressure from the DP or PT and enter the systolic pressure using the keypad in the L ANK location Determining the Pressure at the Left PT Move the hose to the left arm cuff With the Doppler probe on the brachial obtain the left arm pressure and enter this value at L BRA Viewing and Printing the ABI Results Si 14 The ABI for the left leg is displayed after the L BRA pressure is entered The ABI for the right leg can be seen by pressing the SITE key once ABI for the Right Side Press the PRINT key to print the results The display will show Prn Printing will begin immediately if the printer cable is connected and the printer is on Otherwise the LifeDop will continue to display Prn until the printer is connected and on 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 Cut the printed
22. ts 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 considered 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 Troubleshooting Problems 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 aneroid or other accessories Damage to sensitive electrical components speakers cables transducers or plastic l
23. ulated by I 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 Io lt 112 mW cm Note that parameter Z in the probe reporting tables is the same parameter as I in IEC 61157 Operating Conditions There are no user controls which affect the ultrasound output 24 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 2 Safety of UIFaASOUNG sia sccaaiiecinasia oacavedecaworss 3 Product DESCHDIIOM essed 5 Installation and Basic Operation 65 6 Controls Indicators amp Connectors 7 Performing the ABI Examination 10 Interpreting the ExamM ccseceeeeeeeeeeees 15 Maintenance Cleaning ccccceeeeeeeeeeens 18 Troubleshooting Problems 0ceeeeee 21 SPECIICANONS enai a rave haaant 23 VV AVN cx sweehcaamaeinied nase itectemsnnnendaceniatanes 25 Please read the manual carefully and become familiar with
24. w any local state and or national requirements when disposing of used batteries 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 contacts 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 19 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 again as described below Caution Using cleaning solutions other than those specified by Summit Doppler may cause damage to the device
25. wn Caution 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 Controls Indicators amp Connectors Probe Connector On Off ste TA Se Print Headphone Jack Printer Connector o Store Waveform a a Clear On Off Control Turn the LifeDop 300ABI 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 or after 20 minutes if a limb pressure or ankle waveform has been saved 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 NOTE All stored data is erased when power is turned OFF Always print before turning off the power Volume Slider Adjust the audio level by sliding the volume control up or down NOTE The volume slider does not change the headphone volume Site Press the SITE key to change the active storage location shown on the display Each key press advances the storage location one time Available sites are presented in the order that an ABI exam is often conducted including Right Brachial Pressure R BRA Right Ankle Waveform R WAV Right Ankle Pressure R ANK Left Ankle Waveform L WAV Left Ankle Pressure L ANK
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