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GTIN: 00894912002135

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Summary of Contents for Koven Smartdop 45

  • Page 1 GTIN: 00894912002135...
  • Page 2 WARNINGS & CAUTIONS ® CAUTION Use the Smartdop 45 under normal operating conditions, according to the instructions provided in this operation manual and under the operating conditions stated in the product specifications. CAUTION Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
  • Page 3: Table Of Contents

    TABLE OF CONTENTS SECTION 1 (Basic Operation) Warnings & Cautions Introduction ..........................1 Indications for Use ........................1 Features ............................1 1. Indications for Use, Contraindications, & Applications ............2 1-1 Doppler Arterial & Venous Applications ................. …2 1-2 PPG (Photoplethysmography) Arterial & Venous Applications .........2 1-3 Fetal Applications ......................2 1-4 Air Emboli Monitoring ......................2 2.
  • Page 4 TABLE OF CONTENTS 6-2-18 OTHERS - P.ID PRT (Patient Data Print) .............30 6-2-19 OTHERS - PRB-KEY (Probe Button Function) ............30 6-2-20 OTHERS - DATE (Date and Time Setting) ............30 6-2-21 OTHERS - PRB20MHZ (20 MHz Probe Selection) ..........31 Mode Settings for Optional PPG Probe 6-2-22 AC/DC (Arterial/Venous) ..................31 6-2-23 COUNT .........................31 Mode Settings for Optional 2.25 MHz Probe...
  • Page 5 Section 1 Section 1 Basic Operation...
  • Page 6: Warnings & Cautions

    The Smartdop 45 has not been tested for heating or migration in the MR environment. CAUTION Perform ultrasound testing/procedures prudently using the principle of ALARA (As Low As Reasonably Achievable). Smartdop and Smart-V-Link are registered trademarks ® of Koven Technology, Inc.
  • Page 7: Indications For Use, Contraindications, & Applications

    Smartdop ® Basic Operation INDICATIONS FOR USE, CONTRAINDICATIONS, & APPLICATIONS INDICATIONS FOR USE The Smartdop® 45 is used for the detection of arterial and venous blood flow in extremities as well as fetal heart sounds. It displays and prints bidirectional velocity waveform, numerical data and fetal heart rate with heart beat indicator.
  • Page 8: Lower Extremity Doppler Arterial Waveform Pattern Analysis

    Smartdop ® Basic Operation LOWER EXTREMITY DOPPLER ARTERIAL WAVEFORM PATTERN ANALYSIS The Doppler arterial waveforms obtained from the lower extremity may be classified into six categories as an aid in interpretation. TYPE TYPICAL WAVEFORM FINDINGS The contour exhibits a steeply rising upslope at the onset of systole, rapid systolic downslope, and reverse flow (below baseline).
  • Page 9: Controls

    Smartdop ® Basic Operation CONTROLS CONTROLS FRONT LEFT VIEW FRONT LEFT VIEW Scroll Button 1) PAPER COVER Place paper inside To open the paper cover. 2) COVER OPEN BUTTON 3) LCD DISPLAY Displays waveform, numerical data, heart rate, and menu for mode settings. Outputs Doppler sounds.
  • Page 10 Smartdop ® Basic Operation CONTROLS FRONT LEFT VIEW (Cont.) 11) PROBE CONNECTOR 2 To connect a second probe (press the probe button to select) Indicates battery charging status. 12)CHARGING INDICATOR Orange: Charging Green: Fully charged 13) SCROLL BUTTON Consists of 5 internal buttons having the following functions: 14) UP To scroll up through menu items...
  • Page 11: Front Right View & Probe

    Smartdop ® Basic Operation CONTROLS FRONT RIGHT VIEW AND PROBE For probe placement when not in use. 1) PROBE HOLDER 2) COMMUNICATION PORT To connect the Doppler to a computer 3) PROBE To connect the probe To freeze the waveform & numerical data. 4) PROBE BUTTON To activate and deactivate the printer.
  • Page 12: Setup & Operation

    Smartdop ® Basic Operation SETUP & OPERATION TURNING THE UNIT ON / OFF Connect the probe with the alignment mark on Alignment mark the probe connector pointed up (12 o’clock). Press the power button to turn the unit ON. The Doppler will briefly display the type of Power button probe connected.
  • Page 13: Checking The Battery Level

    Smartdop ® Basic Operation SETUP & OPERATION CHECKING THE BATTERY LEVEL The battery level indicator is shown in the upper right corner of the menu screen. Turn the unit on and press the Enter button to display the MENU screen. The battery level indicator shows the battery High level in 4 stages, as shown in the illustration on...
  • Page 14: Charging The Battery

    NOTE Use only the designated adaptor that came with your Smartdop ® 45 or contact Koven Technology for parts & accessories. The charging indicator light will turn solid orange to indicate that charging is in process. When the battery is fully charged, the charging indicator light will turn solid green.
  • Page 15: Installing Printer Paper

    Smartdop ® Basic Operation SETUP & OPERATION INSTALLING PRINTER PAPER Press the Cover Open button on the top of the unit to open the paper cover and remove the paper roll shaft. Insert the roll shaft into the new paper roll. Place the shaft and paper roll in the paper compartment as shown in the illustration on the right.
  • Page 16: Basic Operation

    Smartdop ® Basic Operation BASIC OPERATION MEASURING BLOOD VELOCITY This section explains the fundamentals of using Alignment mark 45 to measure blood velocity. ® the Smartdop For detailed instructions on performing specific tests, please refer to Section 2 Testing Instructions. Connect the probe to probe connector 1.
  • Page 17 Smartdop ® Basic Operation BASIC OPERATION MEASURING BLOOD VELOCITY (cont.) When the waveform becomes rhythmic and stable, wait 5 seconds or more without moving the probe. Then, press the probe button to freeze and/or print the waveform. NOTE The probe button function can be set to PRT&FRZ, PRINT only, or FREEZE only.
  • Page 18: Ppg: Arterial Pulse Waveform Studies

    (Requires the optional PPG probe (PG-21), supplied separately. This section explains the fundamentals of performing a PPG arterial study using the Smartdop 45 with the optional PG-21 Photoplethysmography (PPG) probe. For detailed instructions on performing PPG toe pressures and calculating the Toe Brachial Index (TBI) ratio, please refer to Section 2 Testing Instructions.
  • Page 19: Measuring Fetal Heart Rate (Fhr)

    Smartdop ® Basic Operation BASIC OPERATION MEASURING FETAL HEART RATE (FHR) (2.25 MHz probe, DATA mode) (Required optional fetal probe, supplied separately) Alignment mark This section explains the fundamentals of using the Smartdop ® 45 with a fetal probe to measure fetal heart rate.
  • Page 20: Fetal Heart Rate (Fhr) Monitoring

    Smartdop ® Basic Operation BASIC OPERATION FETAL HEART RATE (FHR) MONITORING (2.25 MHz Monitoring Probe, WAVE mode) (Required optional 2.25 MHz flat monitoring probe, supplied separately) ® This section explains the fundamentals of using the Smartdop 45 with a fetal monitoring probe to monitor fetal heart rate over a period of time.
  • Page 21: Air Emboli Monitoring

    Smartdop ® Basic Operation BASIC OPERATION AIR EMBOLI MONITORING (2.25 MHz Monitoring Probe, BEEP mode) (Requireds optional 2.25 MHz flat monitoring probe, supplied separately) 45 with the 2.25 MHz This section explains the fundamentals of using the Smartdop ® monitoring probe in BEEP mode for performing air emboli monitoring. Alignment mark Connect the 2.25 MHz monitoring probe to the ®...
  • Page 22: Mode & Menu Settings

    Smartdop ® Basic Operation MODE & MENU SETTINGS MENU Various mode settings are available in the MENU. Use the Up and/or Down buttons to scroll through menu options. Some menus have sub-menus. Refer to the following menu structure chart when selecting a mode setting from the menu. 6-1-1 Menu Structure MODE TIME...
  • Page 23: Menu Operation

    Smartdop ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 6-1-2 Menu Operation Press the Enter button on the left side of the Enter Doppler to go to the MENU. The Smartdop ® will display the available menu options. Right Scroll to the desired menu option using the Up Left and/or Down buttons.
  • Page 24: Menu For Blood Velocity Measurement

    Smartdop ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 6-1-3 Menu for Blood Velocity Measurement Mode For measuring blood flow velocity Connect a 5, 8, or 10 MHz probe to select Menu Sub Menu Selections STORE 1 to 30, FREEZE MEMORY READ 1 to 30, FREEZE...
  • Page 25: Menu For Blood Velocity Freeze Mode

    Smartdop ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 6-1-4 Menu for Blood Velocity Freeze Mode For observing waveforms and numerical data Press the probe button to select; press again to exit Menu Sub Menu Selections STORE 1 to 30, FREEZE MEMORY READ 1 to 30, FREEZE...
  • Page 26: Menu For Ppg (Photoplethysmography)(Measurement & Freeze)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 6-1-5 Menu for PPG (Photoplethysmography) (Measurement & Freeze) For measuring and observing PPG waveforms Connect the PPG probe (model PG-21) to select measurement Press the probe button or right button to select freeze; press again to exit Menu Sub Menu Selections...
  • Page 27: Menu For 2.25 Mhz Fetal / Beep Mode

    Smartdop ® Basic Operation MODE & MENU SETTINGS MENU (Cont.) 6-1-6 Menu for 2.25 MHz Fetal / BEEP mode (Measurement & Freeze) For measuring and observing fetal heart rate or performing air emboli monitoring Connect a 2.25 MHz fetal or flat monitoring probe to select measurement Press the probe button or right button to select freeze;...
  • Page 28: Mode Setting Details

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS NOTE ® Once mode settings have been selected, the Smartdop 45 will revert to these setting automatically. However, if the battery life becomes extremely low, the settings will revert back to the default settings.
  • Page 29: Memory - Read

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (cont.) 6-2-2 MEMORY - READ Press Enter to go to the MENU screen. Choose MEMORY and press Enter. Press the Up and/or Down button to choose READ. Press the Right button to highlight the number.
  • Page 30: Mode (Baseline Mode)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (cont.) 6-2-4 MODE (Baseline Mode) Press Enter to go to the MENU screen. Use the Up and/or Down button to choose MODE and press Enter to change. Press Left to exit. Compound mode: Combined forward and reverse components Separate mode:...
  • Page 31: Flow (Blood Volume Flow) / Diameter (Est. Vessel Diameter)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (cont.) 6-2-7 FLOW (Blood Volume Flow) / DIAMETER (Estimated Vessel Diameter) ® The FLOW setting is used to enable the Smartdop 45 to calculate and show blood volume flow MAX and MN values on the DATA display mode.
  • Page 32 Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (cont.) 6-2-8 PATIENT (Patient Data Input) (cont.) To use the data input screen, scroll to the desired letter and press Enter to type it. Press the Back button or enter Backspace ( ) to delete the last letter you typed.
  • Page 33: Others - Language

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (Cont.) 6-2-9 OTHERS - LANGUAGE Press Enter to go to the MENU screen. Scroll using the Up and/or Down buttons to select OTHERS. Press Enter and scroll Up and/or Down to select LANGUAGE. Scroll through the available languages using the Up and/or Down buttons and press Enter to set.
  • Page 34: Disp / Others - Disp (Waveform / Data)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (Cont.) 6-2-14 DISP / OTHERS - DISP (Display Mode) Press Enter to go to the MENU screen and scroll to OTHERS using the Up and/or Down buttons. Press Enter and scroll with the Up and/or Down buttons to DISP. Press Enter to change the Display mode.
  • Page 35: Others - Auto Off (Automatic Shut Off)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (Cont.) 6-2-17 OTHERS - AUTO OFF (Automatic Shut-Off) Press Enter to go to the MENU screen. Scroll using the UP and/or Down buttons to select OTHERS. Press Enter and scroll Up and/or Down to select AUTO OFF. Press Enter to change the mode.
  • Page 36: Others - Prb20Mhz (20 Mhz Probe Selection)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (Cont.) 6-2-21 OTHERS - PRB20MHZ (20 MHz Probe Selection) 45 with a 20 MHz probe, turn option on before connecting the probe. ® To use the Smartdop Press Enter to go to the MENU screen. Scroll using the Up and/or Down button to select 20MHz.
  • Page 37: Sound (Beep Sound For Fhr Mode)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (cont.) 6-2-25 SOUND (Beep sound for FHR mode) Turn on to activate sound alerts when FHR goes outside the specified upper and lower limits when operating in FHR mode. Press Enter to go to the MENU screen.
  • Page 38: Limit-1 (Limit For Beep Mode)

    Smartdop ® Basic Operation MODE & MENU SETTINGS MODE SETTING DETAILS (cont.) 6-2-29 LIMIT-1 (LIMIT for BEEP mode) Sets the limit for receiving beep notifications if the maximum or average waveform exceeds the selected limit during air emboli monitoring. Press Enter to go to the MENU screen. Scroll using the Up and/or Down button to select LIMIT-1.
  • Page 39: Lcd Display

    Smartdop ® Basic Operation LCD DISPLAY BLOOD VELOCITY MODE 7-1-1 WAVEFORMS The baseline on the LCD is automatically located at best position. The Smartdop ® has 4 baseline settings; bottom, 1/4 from bottom, center, and 3/4 from bottom. Waveform amplitude is automatically adjusted. Amplitude scale (velocity or frequency per division) is displayed in the upper left corner of the LCD.
  • Page 40: Numerical Data

    Smartdop ® Basic Operation LCD DISPLAY BLOOD VELOCITY MODE (Cont.) 7-1-2 NUMERICAL DATA The following numerical parameters are displayed in DATA mode. Unit: kHz Unit: cm/s See 9. “Numerical Data” for abbreviations and parameter definitions. FETAL HEART RATE MODE 7-2-1 DISPLAYING REAL TIME FHR (DATA Mode) 45 has received sufficient ®...
  • Page 41: Monitoring Fhr In Graph (Wave Mode)

    Smartdop ® Basic Operation LCD DISPLAY FETAL HEART RATE MODE (Cont.) 7-2-2 MONITORING FHR IN GRAPH (WAVE mode, Monitoring Mode) The heart rate measurement range is 60 to 220 bpm. Real-time heart rate is displayed on the bottom left corner of the screen. FHR monitoring waveform Heart rate Upper limit...
  • Page 42: Printing Waveforms & Data

    Smartdop ® Basic Operation PRINTING WAVEFORMS & DATA MODE SETTINGS INFLUENCING THE PRINTED CHART The following settings influence the printed waveform and data. Change settings before printing if required. Mode Abbrev. Selection Baseline mode MODE Compound, Separate Time scale TIME Normal, Slow Flow direction DIR Forward, Reverse...
  • Page 43: Print Sample

    Numerical Waveform mode data area Probe frequency NOTE Thermal paper tends to fade over time. For archiving printed records, please photocopy your record. Certain plastic file folders may accelerate fading. Koven Technology does not take responsibility for thermal paper fade.
  • Page 44: Numerical Data

    Smartdop ® Basic Operation NUMERICAL DATA Parameters Abbr. Definitions Systolic velocity [cm/s] or systolic Doppler shift [kHz] Mean velocity [cm/s] or mean Doppler shift [kHz] Diastolic velocity [cm/s] or diastolic Doppler shift [kHz] Minimum velocity [cm/s] or Minimum Doppler shift [kHz] Resistance Parameter RP = (S - D) / S RP = 1 if waveform goes below...
  • Page 45: External Outputs

    Smartdop ® Basic Operation 10. EXTERNAL OUTPUTS 10-1 HEADSET When using an external headset (not provided), sound to the speaker will be cut off. 10-2 COMMUNICATION PORT (3.5 mm Jack) To observe the waveform in high resolution on a PC monitor or to store the waveform and numerical data into a computer for future reference, or to create a report of standardized testing modules.
  • Page 46: Maintenance

    Recharge every 3 months under normal temperature (20° C). Recharge every month under special conditions, high temperatures, around 40° C. NOTE Battery life is approximately 300 full charges. When charge life becomes obviously short, contact Koven for battery replacement. 12. SYMBOL LIST Symbols Descriptions...
  • Page 47: Operating Principles

    Smartdop ® Basic Operation 13. OPERATING PRINCIPLES 45 bidirectional Doppler is designed to obtain blood flow velocities through the The Smartdop ® use of ultrasound, which is transmitted from the probe to the patient’s body and reflected by the blood (hemocyte, etc.). The unit amplifies the high frequency oscillation output and then supplies it to the transmitter transducer.
  • Page 48: Block Diagram

    Smartdop ® Basic Operation 14. BLOCK DIAGRAM Printer Battery Power Power Pre- Switching Speaker amplifier amplifier supply circuit Charging circuit Headset Probe adaptor Foot Temp Probe...
  • Page 49: Specifications

    Smartdop ® Basic Operation 15. SPECIFICATIONS Freq. Model# GTIN# Ispta* (in situ) [mW/cm²] Probes (For transcutaneous use): 2 MHz BT2M20S8C 00894912002326 94 mW/cm² or less 5 MHz BT5M05S8A 00894912002333 720 mW/cm² or less 8 MHz BT8M05S8A 00894912002357 720 mW/cm² or less 10 MHz BT10M5S8A 00894912002302...
  • Page 50: Operation Storage & Transport Environments

    Smartdop ® Basic Operation 16. OPERATION, STORAGE & TRANSPORT OPERATING ENVIRONMENT • 10 to 37°C • 85% humidity or less with no condensation CAUTION Do not drop or place in an area where the unit may fall. CAUTION Do not use simultaneously with an electrocautery defibrillator, other ultrasonic device or a mobile phone.
  • Page 51: Cleaning

    Smartdop ® Basic Operation 18. CLEANING Clean the Doppler & probes after use. DOPPLER BOX To clean the Doppler box, wipe down with a damp cloth, then with a soft dry cloth. Take care not to allow water to penetrate the unit. CAUTION The Doppler box should not have direct contact with the patient or be placed in the sterile area.
  • Page 52: Disposal Of Device

    Warranty periods on probes, adaptors & accessories vary. Please refer to your purchase invoice for additional warranty terms. In the event of malfunction during the warranty period, please contact Koven Technology, Inc. at 314-542-2101 or info@koven.com. The warranty does not cover defects resulting from accidents or misuse and is void if modifications of parts are attempted without permission.
  • Page 53: Safety Standards

    Smartdop ® Basic Operation 21. SAFETY STANDARDS The Smartdop ® 45 conforms to the following standards: Manufacturing standard: IEC60601-1 Protection class against electric shock : Class II device : Internally powered equipment Protection grade against electric shock : Type BF applied part Guidance and manufacturer’s declaration : electromagnetic emissions and immunity Guidance and Manufacturer’s Declarations...
  • Page 54 Smartdop ® Basic Operation Guidance and Manufacturer’s Declarations (cont.) Electromagnetic Immunity 45 is intended for use in the electromagnetic environment specified below. The user of The Smartdop ® 45 should assure that it is used in such an environment. ® the Smartdop Immunity test IEC60601 test level...
  • Page 55 Smartdop ® Basic Operation Guidance and Manufacturer’s Declarations (cont.) Electromagnetic Immunity (cont.) 45 is intended for use in the electromagnetic environment specified below. The user of The Smartdop ® 45 should assure that it is used in such an environment. the Smartdop ®...
  • Page 56 Section 2 Section 2 Testing Instructions...
  • Page 57: Ankle Brachial Index

    Smartdop ® Vascular Testing Instructions 1. ANKLE BRACHIAL INDEX (ABI) The Ankle Brachial Index is the ratio of the highest systolic pressure at the arm to the systolic pressure at the ankle. This simple test is performed much like taking a standard blood pressure, except that a Doppler is used instead of stethoscope.
  • Page 58 Smartdop ® Vascular Testing Instructions 1. ANKLE BRACHIAL INDEX (ABI) (Cont.) Take the systolic pressures at the ankle Before taking the systolic pressures at the ankle, take a print out of the Doppler waveform at the Dorsalis Pedis and/or Posterior Tibial arteries by following the instructions for taking a waveform printout as described in Section 1 5-1 “Measuring Blood Velocity”...
  • Page 59: Segmental Blood Pressures

    Smartdop ® Vascular Testing Instructions 2. SEGMENTAL BLOOD PRESSURES Segmental pressure studies are performed with the same method as an Ankle Brachial Index, but incorporate additional cuffs wrapped above and below the knee and optionally at the high thigh, in addition to the ankle.
  • Page 60 Smartdop ® Vascular Testing Instructions 2. SEGMENTAL BLOOD PRESSURES Interpreting the Results Observe pressure differences between adjacent cuff sites on the same leg. Pressure differences between cuff sites are used to localize the disease. Pressure difference between two adjacent levels of less than 20 mmHg is considered normal within limits.
  • Page 61: Venous Compression Studies

    Smartdop ® Vascular Testing Instructions 3. VENOUS COMPRESSION STUDIES Venous compressions are auditory tests consisting of 2 maneuvers. These are, compression of the metatarsal arch to verify augmentation followed by compression of the calf muscle to verify valvular competence. Venous compressions are performed to detect enlarged veins due to the presence of malfunctioning valves.
  • Page 62 Smartdop ® Vascular Testing Instructions 3. VENOUS COMPRESSION STUDIES Interpreting the Results During proximal compression, a brief loud sound that rapidly concludes as blood movement is stopped by competent valves, is expected. A long sound that continues as long as compression is applied may indicate valvular incompetence.
  • Page 63: Ppg Toe Pressures & Toe Brachial Index (Tbi)

    Smartdop ® Vascular Testing Instructions 4. PPG TOE PRESSURES & TOE BRACHIAL INDEX (TBI) Requires the optional PPG probe {PG-21}, supplied separately. PPG (photoplethysmography) toe pressure studies and related TBI’s (Toe Brachial Index) are performed to assess the vascular condition of the foot by obtaining systolic pressures at the toe.
  • Page 64: Ppg Venous Reflux

    Smartdop ® Vascular Testing Instructions 4. PPG TOE PRESSURES & TOE BRACHIAL INDEX (TBI) (Cont.) Watch the LCD and wait for steady cyclic waveform motion to appear . NOTE If the waveform is not steady or absent, check the sensor for good contact, the limb for possible vasoconstriction, and the pulse for ectopic beats.
  • Page 65 Smartdop ® Vascular Testing Instructions 5. VENOUS REFLUX Requires the optional PPG probe {PG-21}, supplied separately. Venous reflux studies use a PPG probe affixed adjacent to the posterior tibial artery. The patient is asked to dorsiflex the foot, which acts as a pump for venous augmentation.
  • Page 66 Smartdop ® Vascular Testing Instructions 5. VENOUS REFLUX (Cont.) Ask the patient to dorsiflex the foot the specified number of times, following the animation on the LCD. The exercise should be performed forcefully, especially when lifting the foot upward. After dorsiflexing, the patient should relax the foot and avoid all movement.
  • Page 67 Distributed by: Koven Technology, Inc. 477 N. Lindbergh Blvd., Suite 220 St. Louis, MO 63141 Tel: 800-521-8342 • Fax: 314-542-6020 E-mail: info@koven.com www.koven.com GLN: 0894912002005 OM-1254 rev8 Smartdop 45 Operation Manual Copyright © Koven Technology, Inc.

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