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Thank you for choosing the
Smartdop

30EX…

The Smartdop® 30EX is a bidirectional Doppler with LCD display, integrated printer

and automatic cuff inflator. It is used for the detection of arterial and venous blood

flow in extremities.

Please read this manual carefully to acquaint yourself with the

proper operation.

Smartdop and Smart-V-Link are registered trademarks ® of Koven Technology, Inc.

FEATURES

• Bidirectional Doppler with LCD, cuff inflator, & integrated printer

Displays and prints velocity waveforms and numerical data

Automatic cuff inflation / deflation

Automatically calculates and prints ABI / TBI and velocity / pressure

•

Convenient probe activation button

Freezes and/or prints waveform and numerical data for documentation purposes

Inflates and/or dumps the cuff

•

Automatic Power “OFF”

To conserve battery life

•

USB computer interface & optional software

Transfers waveforms and numerical data to a computer for data storage & EMR’s

USB communication cable and Smart-V-Link

software are optional

•

30 Waveform Memory

Save patient waveforms and numerical data for later use or download to the optional Smart-V-Link

software

•

Optional PPG (Photoplethysmography) probe available for expanded arterial and
venous testing

NOTE

If using the Smartdop

30EX with the optional Smart-V-Link

documentation software, please

refer to the Smart-V-Link

operation manual for instructions on downloading waveforms and

performing tests with the Doppler and software.

Manufactured by:

Hadeco, Inc.

2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003 Japan

CAUTION

Use the Smartdop

30EX 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.
RX only.

CAUTION

The Smartdop

30EX has not been evaluated for safety and compatibility in the MR environment.

The Smartdop

30EX 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).

Содержание Smartdop 30EX

Страница 1: ...GTIN 00894912002098...

Страница 2: ...asound gel included with purchase is non sterile and should only be used noninvasively WARNING Discontinue use of ultrasound gel if an allergic reaction occurs CAUTION The probe transducer tip is thin...

Страница 3: ...area The Doppler box cannot be sterilized or reprocessed WARNING The Doppler box and noninvasive probes should be cleaned following any patient contact CAUTION Do not submerge the Doppler box or probe...

Страница 4: ...Battery Level 10 4 3 Charging the Battery 10 4 4 Installing the Printer Paper 11 4 5 Measuring Blood Velocity 12 13 5 Mode Menu Settings 5 1 Basic Mode Settings 14 5 2 Other Modes 5 2 1 Measurement F...

Страница 5: ...ut Keys 31 6 LCD Display 6 1 Blood Velocity Modes 6 1 1 Waveforms 32 6 1 2 Numerical Data 32 6 2 Pressure Modes Arm Leg and Toe Modes 6 2 1 Display Samples 33 6 2 2 Error Messages 34 6 3 Battery Indic...

Страница 6: ...osal of Device 46 18 Warranty 46 19 Safety Standards 47 49 SECTION 2 Testing Instructions 1 Ankle Brachial Index 50 53 2 Segmental Blood Pressures 54 56 3 Venous Compression Studies 57 4 PPG Toe Press...

Страница 7: ...Section 1 Section 1 Basic Operation...

Страница 8: ...software are optional 30 Waveform Memory Save patient waveforms and numerical data for later use or download to the optional Smart V Link software Optional PPG Photoplethysmography probe available fo...

Страница 9: ...dex ABI studies Systolic pressures Peripheral vascular procedures Blood flow velocity Segmental Pressure studies Penile digit systolic pressures Venous compressions 1 2 PPG PHOTOPLETHYSMOGRAPHY AND PU...

Страница 10: ...ent and loss of reverse flow The width of systolic pulse is broad ened The Doppler sounds are diminished very little as compared to the type O pattern II The contour shows prolongation of both the ups...

Страница 11: ...e of the dicrotic notch More significant occlusions will show a decreased slope of the ascending and descending segments and a rounding of the systolic peak occurs More serious obstructions will show...

Страница 12: ...ocumentation 2 SPEAKER Outputs Doppler sounds 3 VOLUME CONTROL To adjust sound volume 4 PROBE HOLDER 1 For probe placement when not in use 5 PROBE HOLDER 2 For probe placement when not in use 6 INFLAT...

Страница 13: ...TTINGS for details 3 PRINT BUTTON To activate deactivate the printer Menu mode Moves the cursor up 4 MENU BUTTON To enter Menu mode See 5 3 MENU for details Turns the backlight ON OFF 5 PROBE SELECTIO...

Страница 14: ...se pressure values Arm Leg or Toe Modes To change the display mode Waveform Numerical Mode 1 or Mode 2 during measurement See 5 2 2 Display Mode for details Menu mode Moves the cursor down Magnifies t...

Страница 15: ...APTOR To connect the designated AC adaptor CONNECTOR 6 POWER SWITCH To turn the unit ON OFF 7 HEADSET To connect a headset not provided Cuts off sound to the speaker 8 PROBE Multi probe selection 5 8...

Страница 16: ...ottom left corner of the LCD as shown in the illustration on the right Although the Smartdop will continue to operate it is recommended that the battery be recharged as soon as possible See 4 3 CHARGI...

Страница 17: ...the right 3 Charge the battery when the indicator shows that the battery level is low High Medium Low Empty Battery level indicator AC adaptor connector Mode LEDS NOTE It takes approximately 4 hours...

Страница 18: ...mount of paper has been fed through press the PRINT button again to stop the printer Pull the edge of the paper out a few inches and tear off at the paper guide Snap the roll shaft with the paper into...

Страница 19: ...e patients skin Make sure there is enough gel to cover the tip of the probe 5 Place the probe on the measurement area at an angle of 45 to 60 against flow and adjust to locate the best sounds 12 Probe...

Страница 20: ...ction must be set to PRINT or FRZ PRINT 8 To save the waveform and numerical data in memory see 5 3 8 MEMORY STORE for details 9 Press the INF DUMP button or the probe button to exit freeze mode and r...

Страница 21: ...d Mode 2 WAVE Displays waveform DATA Displays numerical data The Smartdop 30EX has the following 6 basic mode settings Mode Type of Test How to Select Mode 1 Arterial AC Press the MODE button Blood Ve...

Страница 22: ...lable submenu options using the PRINT up or LEG TOE down buttons Press the Enter or Right button to select the item or change the setting 3 Press the ARM left button to return to the previous screen o...

Страница 23: ...ettings 1 DISCHARGE is available when the AC adaptor is connected to the main unit 5 MODE MENU SETTINGS 16 Menu Submenu Selections Reference Section MEMORY READ 1 to 30 FREEZE 7 3 9 CLEAR 1 to 30 ALL...

Страница 24: ...e AC adaptor is connected to the main unit 5 MODE MENU SETTINGS Menu Submenu Selections Reference Section STORE 1 to 30 FREEZE 5 3 8 MEMORY READ 1 to 30 FREEZE 5 3 9 CLEAR 1 to 30 ALL 5 3 10 DIR direc...

Страница 25: ...SOR and P DISP are available only in freeze mode 3 MEMORY STORE is available only in freeze mode 4 DISCHARGE is available when the AC adaptor is connected to the main unit 18 Menu Submenu Selections R...

Страница 26: ...mode only 2 COUNT is available in Mode 2 DC during measurement mode only 3 MEMORY STORE is available only in Freeze mode 4 DISCHARGE is available when the AC adaptor is connected to the main unit 19...

Страница 27: ...indicate default settings 1 WAVEFORM is available only in freeze mode 2 MEMORY STORE is available only in freeze mode 3 DISCHARGE is available when the AC adaptor is connected to the main unit Menu Su...

Страница 28: ...own to select it Press the INF DUMP button right to highlight the memory number The first available number will be automatically be selected To change the memory number scroll up PRINT button or down...

Страница 29: ...view is highlighted Press the probe selection button enter to read the data Press the probe selection button enter again to view the next waveform To view the previous waveform press the Mode button a...

Страница 30: ...ction from forward to reverse Press the MENU button to go to Menu mode Scroll up PRINT button or down LEG TOE button until DIR flow direction is highlighted Press the probe selection button Enter or I...

Страница 31: ...OTHERS is highlighted Press the probe selection button Enter or INF DUMP Right to select the submenu Scroll up or down until DISP is highlighted Press the probe selection button Enter or INF DUMP but...

Страница 32: ...f of waveform ARM LEG and TOE Pressure Modes Press the MENU button to go to Menu mode Scroll up PRINT button or down LEG TOE button until WAVEFORM is highlighted Press the INF DUMP Right button to cha...

Страница 33: ...hted Press the probe selection button Enter or INF DUMP Right to bring up the submenu Scroll up or down until LANGUAGE is highlighted Press the probe selection button enter or INF DUMP button right to...

Страница 34: ...on button Enter or INF DUMP button Right to bring up the submenu Scroll up or down until BACKLIGHT is highlighted Press the probe selection button Enter or INF DUMP Right to change the setting ON Turn...

Страница 35: ...THERS DISCHARGE DISCHARGE is used to discharge the battery prior to recharging The Discharge option is available when the AC Adaptor is connected to the main unit Press the MENU button to go to Menu m...

Страница 36: ...pressure point Press Enter to set the new pressure point or press MENU to cancel Once the CURSOR has been adjusted press Enter to set then press the MENU button to exit and return to the previous scre...

Страница 37: ...seconds 5 3 26 COUNT COUNT is used to set the number of times the patient should dorsiflex the foot during Venous Reflux studies It is available when the optional PPG probe is connected and the MODE i...

Страница 38: ...ressure 5 3 23 MODE LEFT Move cursor left Pressure 5 3 23 MODE DOWN Zoom IN OUT Pressure 5 3 13 ENTER View next waveform Freeze MODE ENTER Previous waveform Freeze ARM or LEG TOE BP Clear Pressure 5 3...

Страница 39: ...4 Freeze the waveform by pressing the INF DUMP button or the probe button probe button function must be set to FREEZE or FRZ PRINT Smartdop 30EX will stop monitoring and display the frozen waveform on...

Страница 40: ...After cuff inflation and deflation press the ARM or LEG TOE button to temporarily save the pressure in memory for calculating the ABI or TBI ratio 2 If you would like to clear the pressure data press...

Страница 41: ...INDICATOR When the battery is low the low battery indicator will be displayed in the bottom right of the LCD screen Recharge the battery See 4 3 CHARGING THE BATTERY for details Low battery indicator...

Страница 42: ...printing Mode 1 Waveform of the 5 seconds prior to printing Mode 2 Waveform of the 25 seconds prior to printing Freeze Mode Mode 1 Waveform of the 5 seconds prior to freezing Mode 2 Waveform of the 25...

Страница 43: ...VEFORMS DATA 7 2 PRINT SAMPLES Mode 1 Arterial Time scale 0 2 sec div approx 25 mm s Combined forward and reverse Mode 2 Venous Time scale 1 sec div approx 5 mm s Separation of arterial and venous flo...

Страница 44: ...press print button longer than 2 seconds Pressure Velocity Arm only Leg only Toe only Arm Leg Arm Toe Arm Leg Toe Save the arm pressure last Sound reappearance NOTE Thermal paper tends to fade over ti...

Страница 45: ...Most recent 10 second average measurement mode First 10 second average freeze mode 7 4 4 STEP CALIBRATION The Calibration Print CAL PRINT option is available in Mode 1 and Mode 2 To print the 4 step c...

Страница 46: ...to the Smart V Link Operation Manual included with software purchase NOTE For Smart V Link operation refer to the Smart V Link Operation Manual included with software purchase 9 MAINTENANCE PERFORMANC...

Страница 47: ...Headset 10 Mode button 3 USB connector 11 Print button 4 AC adaptor connector 12 Menu button 5 Probe connector 13 Arm button 6 Caution 14 Leg Toe button 7 Power ON 15 Probe selection button 8 Power O...

Страница 48: ...adset Simultaneously the Doppler shift signals are applied to the CPU and converted to blood flow velocity waveform signals which can be displayed and printed While in the Arm Leg and Toe Pressure mod...

Страница 49: ...Frequency Amplifier High Frequency Output High Frequency Oscillator Transducers Main Unit Probe 12 BLOCK DIAGRAM 42 Probe 2 Probe Selector Pre Amplifier Comparator Phase Detection CPU Pressure Sensor...

Страница 50: ...te 30 to 240 bpm Battery level and low battery indicators Blood Pressure data pressure profile ABI TBI PV Arterial waveform Printer Paper 58 mm W x 25 m L per roll thermal Resolution 332 dots per line...

Страница 51: ...002777 Vascular cuffs PPG toe clips FAST Sphyg GTIN 00894912002920 CAUTION Do not drop or place in an area where the unit may fall CAUTION Do not use simultaneously with an electrocautery defibrillato...

Страница 52: ...If an enzymatic cleaner is used wipe down again using alcohol and a soft cloth Hospital approved alcohol based wipes are an acceptable alternative to a soft cloth CAUTION Do not submerge the Doppler...

Страница 53: ...obes 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...

Страница 54: ...ons test compliance Electromagnetic environment guidance RF emissions Group 1 The Smartdop 30EX uses RF energy only for its internal function Therefore the RF emissions are very low and CISPR 11 are n...

Страница 55: ...nment IEC61000 4 4 1kV for input output 1kV for input output lines lines Surge 1kV differential 1kV differential Mains power should be that of a mode mode typical commercial or hospital IEC61000 4 5 2...

Страница 56: ...as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symb...

Страница 57: ...Section 2 Section 2 Testing Instructions...

Страница 58: ...ms are steady and the INF DUMP LED begins to blink press the INF DUMP or probe button to activate the automatic cuff inflator The Smartdop 30EX will automatically inflate the cuff past the point of pr...

Страница 59: ...he first arm pressure and save the new pressure If the pressure of the second arm is lower do not press the ARM button and the first pressure will be used for the calculations 9 If you would like to s...

Страница 60: ...If you would like to save the data in memory see 5 3 8 MEMORY STORE for details 8 Press the INF DUMP button to return to the monitoring screen and repeat on the other leg 1 ANKLE BRACHIAL INDEX ABI C...

Страница 61: ...e Obstruction Waveform Examples 1 40 Noncompressible 1 00 1 40 Normal 0 91 0 99 Borderline 0 00 0 90 Abnormal Creager MA et al 2011 2012 ACCF AHA ACR SCAI SIR STS SVM SVN SVS Key Data Elements and Def...

Страница 62: ...m as described in the instructions for performing an Ankle Brachial Index Take the systolic pressures at the leg Before taking the systolic pressures at the leg take printouts of the Doppler waveforms...

Страница 63: ...need to press the LEG TOE button when taking pressures below the knee above the knee and at the high thigh This button is used exclusively to calculate the ABI However pressing the INF DUMP button to...

Страница 64: ...n two adjacent levels of less than 20 mmHg is considered normal within limits NOTE Lower extremity ankle systolic pressures may be falsely elevated in patients with calcified non compressible arteries...

Страница 65: ...hand 6 The Smartdop 30EX will display the dual baseline reflecting the augmented or diminished sounds Press the probe button or INF DUMP button to freeze the waveform Venous Augmentation NOTE The prob...

Страница 66: ...d thus may affect the accuracy of PPG measurements 2 Affix the PPG sensor with the clear side against the skin surface using double sided clear tape or a PPG toe clip Wrap a digit cuff snugly around t...

Страница 67: ...tor The Smartdop 30EX will automatically inflate the cuff past the point of pressure cessation then slowly deflate the cuff until waveform motion returns 4 Press the LEG TOE button to store the toe pr...

Страница 68: ...Elements and Definitions for Peripheral Atherosclerotic Vascular Disease A Report of the American College of Cardiology Foundation American Heart AssociationTask Force on Clinical Data Standards Writi...

Страница 69: ...to change the number of times the patient should dorsiflex during the test press the MENU button and scroll up PRINT button or down LEG TOE button until COUNT is highlighted Press the probe selection...

Страница 70: ...NF DUMP or probe button probe button function must be set to FREEZE or FRZ PRINT to exit FREEZE mode 11 To rule out superficial venous reflux and direct augmentation to the deep veins the test can be...

Страница 71: ...egs at the desired locations Sites can include the high thigh at the groin above and below the knee ankle transmetatarsal and toe 4 Connect one end of the tubing to the inflation inlet on the front of...

Страница 72: ...EX Operation Manual Copyright Koven Technology Inc 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 08949...

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