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Hadeco Smartdop XT, Руководство по эксплуатации

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1 

1. Introduction 

 

Thank you very much for choosing the Smartdop XT. 

 
The Hadeco Smartdop XT is a fully automatic total vascular testing system for ABI and TBI 
studies that works with a Windows software Smart-XT-Link including automated blood 
pressure & pulse volume measurement capabilities for up to 6 sites with simple one-button 
operation as well as up to 14 sites with rolling basis segmental testing. 
Please read this manual carefully to acquaint yourself with the unit operation. 
This medical device can be used for the purposes mentioned in "Clinical

 

Applications" for 

patients in hospitals and clinics. 
 

1-1. Features 

  One button operation for up to 6-site automatic blood pressure measurements by 

oscillometry & PPG for ABI, TBI, and PV-Arterial studies.   

  Up to 6-site semi-automatic blood pressure measurements by Doppler & PPG for 

ABI & TBI along with Doppler and PV arterial studies. 

  Segmental blood pressures for up to 14 sites with rolling basis operation 

  PPG Venous reflux study with dual PPG probes. 

  Foot temperature study available with optional temperature probe.   

  All tests controlled & stored by computer with Smart-XT-Link for Windows that 

includes capabilities to print waveform data and export to DICOM. 

 

1-2. Clinical applications 

To diagnose peripheral vascular disease: 

  ABI and TBI studies 

  Blood pressure segmental studies 

  PV arterial studies 

  Bi-directional Doppler lower extremity studies 

  PPG toe pressure & venous reflux studies 

  Foot temperature studies 

 

1-3. System requirements 

MAIN UNIT:

 

Smartdop XT 

SOFTWARE: 

Smart-XT-Link for 6 ports for Windows 

COMPUTER 

 

 

OS: 

Windows Vista/ 7/ 8.1 

 

 

CPU clock:   

Celeron 1GHz or more 

 

 

Display:   

800 x 600 dots or more 

 

 

 

 

256 colors or more 

 

 

Minimum memory requirements: 

 

 

 

 

RAM: 

1 GBytes or more   

 

 

 

 

HDD: 

40 MBytes or more 

 

 

USB:   

USB2.0 or more

 

Содержание Smartdop XT

Страница 1: ......

Страница 2: ...ther segmental studies 13 4 4 Doppler Arterial Testing 15 4 5 PPG Venous Reflux 19 4 6 Foot Temperature 21 5 Menu 23 5 1 SaveFile 23 5 2 Search Files 23 5 3 New File 24 5 4 Print Report 25 5 5 Patient Information 25 5 6 Symptoms Diagnosis 25 5 7 Default Data 26 5 8 Option Screen 26 6 Maintenance 28 6 1 Performance check by user 28 6 2 Cleaning 28 6 3 Warranty 28 7 Supplemental information 29 7 1 S...

Страница 3: ...e unit operates safely and correctly by implementing simple check before use mentioned in 6 1 Performance check by user 3 Make sure that all cables and components are connected correctly and safely 4 Using it with other equipment together may cause a misdiagnosis or danger to patient due to a malfunction 5 Double check that all the cables and components do not obstruct any external connection to t...

Страница 4: ...Probes 1 Clean the probe using damp cloth before use Using alcohol or thinner may damage the probe 2 The probe transducer tip is very thin and delicate Please handle with great care and use the probe cap when not in use 11 Ultrasonic gel 1 Do not apply ultrasonic gel to the Doppler probe body other than the tip of probe 2 Using other materials such as baby oil and cream may damage the probe 3 The ...

Страница 5: ...ing with EN60601 1 to connect to the unit 3 Connection of the connected computer to a network that includes other equipment such as network printer could result in previously unidentified risks to patients or operators and the user of the unit should identify analyze and control such risks 4 Subsequent changes to network could introduce new risks and require new analysis and changes to network inc...

Страница 6: ......

Страница 7: ...tic blood pressure measurements by Doppler PPG for ABI TBI along with Doppler and PV arterial studies Segmental blood pressures for up to 14 sites with rolling basis operation PPG Venous reflux study with dual PPG probes Foot temperature study available with optional temperature probe All tests controlled stored by computer with Smart XT Link for Windows that includes capabilities to print wavefor...

Страница 8: ... Foot temperature probe connector To connect foot temperature probe option 7 Stop button To stop testing and dump all cuffs immediately while in measurement 8 Charge indicator To indicate battery charging status as follows Orange LED Charging battery with AC adaptor LED turns off When battery fully charged See 3 1 Charging battery for details 9 Power indicator To indicate the power status as follo...

Страница 9: ... be adjusted on each testing screen of Smart XT Link software Rear view 12 Power switch ON OFF To turn the unit ON and OFF 13 AC adaptor connector To connect designated AC adaptor 14 Serial port To connect computer with designated USB cable 11 12 13 14 SmartdopXT ...

Страница 10: ...toe PPG waveforms for toe and transmetatarsal pressures 16 Doppler probe button To freeze and unfreeze the waveform 17 Doppler transducer To detect blood velocity 18 Probe cap To protect the transducer tip when not in use 19 Temperature probe button To record the foot temperature 20 Temperature transducer To detect foot temperature 19 20 16 17 18 15 ...

Страница 11: ...le Patient Information To input patient data Symptoms Diagnosis To input symptoms and diagnosis for patient Default Data To input and or revise Default Data Facility data Performing Studies and Requesting Physician Options To set optional settings for CommPort Language DICOM data folder and others Launcher icons Automatic Arterial Testing PPG Venous Reflux Doppler Arterial Testing Foot Temperature...

Страница 12: ...n process is completed Smart XT Link will start automatically with Default Data screen 3 2 2 Installing USB Cable Driver 1 Set the Smart XT Link for 6 ports V1 0 CD ROM on your CD ROM drive 2 If automatic installer Smart XT Link for 6 ports Ver1 0 installation pops up click on Cancel 3 Connect the Smartdop XT to your computer by using the USB cable enclosed The following procedures depend on your ...

Страница 13: ...ink 1 Before uninstalling Smart XT Link copy all the waveform data saved on the WaveData folder for future reference The initial WaveData is located in C Hadeco SXTLink6_1 0 Default 2 Select Hadeco Smart XT Link6 Ver1 0 Uninstall Smart XT Link6 Ver1 on Program menu to uninstall Smart XT Link Note Smart XT Link does not support both Windows power options of Sleep and Suspend and thus disable the op...

Страница 14: ... Link and Patient Information screen will appear 5 Type the patient information or you may do it later 6 Click Save to save the information and it will go to Main Screen 7 Click Options and do Search Comm once to search for COM port where the unit is connected and Smart XT Link will show the COM port Do the other settings desired on Option Screen See section 5 8 Option Screen for more details 8 Cl...

Страница 15: ... and ankles DVC 1 9 2 pcs For great toes Tubing 2 tubing each color x 3 sets White for Arm Green for Ankle PT Black for Great toe Tubing with blue mark at both ends are for the right side PPG probe PG 01 x 2 pcs PPG clip PPG Clip x 2 pcs 2 Click Automatic Arterial Testing launcher icon on Main Screen 3 Settings Click Settings button on Automatic Arterial Testing screen and set the Auto testing ord...

Страница 16: ... click Remove button to proceed Click buttons to get the removed window s back 4 2 2 Starting Automatic Arterial Testing 1 Wrap cuffs snugly on each side of brachium ankle and great toe Note Use appropriately sized cuffs for each patient 2 Hook up each color coded tubing between cuff and the inflation port with the same color as tubing s for each site 3 Connect 2 PPG probes to the unit and affix e...

Страница 17: ... shown below will appear Click OK to close it and ABI and TBI will be calculated automatically during the tests After all testing is completed Smartdop will dump all cuffs with beeping automatically Note ABI Ankle pressure Brachial pressure TBI Toe pressure Brachial pressure Enlarging waveform Right click one of PV waveform windows to enlarge it and the Individual waveform screen will appear for w...

Страница 18: ...waveform 1 Click the PV waveform window where you wish to test manually and Smartdop will start PV testing Manual testing of blood pressure testing 1 Click the pressure icon where you wish to test manually 2 Select Take pressure in pull down menu to start testing Select Take pressure ...

Страница 19: ... ankles will be used for the segmental testing at high thigh above knee below knee and transmetatarsal DP as well as ankle PT 2 Click Settings button and set the Auto testing order and click Save to set the settings 3 Sound adjustment See the step 7 in the 4 2 1 Preparations for sound adjustment 4 Removing waveform window s See the step 8 in the 4 2 1 Preparations for removing the window s 4 3 2 S...

Страница 20: ...res Note Auto start button changes to Stop button while in testing Click Stop button to stop the testing Note On Doppler Arterial Testing ankle cuff is used for taking transmetatarsal DP pressure as shown in the right 3 When all tests are completed the dialog box as shown right will appear Click OK to close it Smartdop will dump all cuffs automatically while beeping ...

Страница 21: ...tion VC 10 4 pcs For brachia and ankles DVC 1 9 2 pcs For great toes Tubing 2 tubing each color x 3 sets White for Arm Green for Ankle PT Black for Great toe Tubing with blue mark at both ends are for the right side PPG probe PG 01 x 2 pcs PPG clip PPG Clip x 2 pcs Doppler probe Option BT8M05S8C x 1pc Ultrasonic gel TSUBAKIYA for Doppler testing Option 2 Click Doppler Arterial Testing launcher ico...

Страница 22: ...Preparations for the details 5 Removing waveform window s See the step 8 in the 4 2 1 Preparations for removing the window s 4 4 2 Starting Doppler Arterial Testing 1 Wrap cuffs snugly on each site of brachium ankle and great toe Note Use appropriately sized cuffs for each patient 2 Hook up each color coded tubing between cuff and the inflation port with the same color as tubing s for each site 3 ...

Страница 23: ...t ultrasonic gel on tip of Doppler probe Place the probe to the artery with an angle of 45 to 60 degrees and move it slowly to locate the point where the maximum sounds are heard Adjust sound volume if necessary Note Smartdop always restart Auto testing by re clicking Auto Start from where any testing has been cancelled 7 When all tests are completed on Doppler Arterial Testing screen the dialog b...

Страница 24: ...for more details 4 4 3 Further segmental studies If desired further blood pressure segmental studies can be performed with the Smartdop on rolling basis operation for up to 14 sites on both Automatic Arterial Testing and Doppler Arterial Testing screens See 4 3 Further segmental studies for Automatic Arterial Testing 4 4 4 Monitoring screen Each of monitoring screens will show up while performing ...

Страница 25: ... icon on main screen to go to PPG Venous Reflux screen 3 Click Settings button on the screen and set PPG Venous Reflux settings as follows Test mode Select either Single test or Dual test for testing right and left legs separately or simultaneously respectively Count Type the number of times for patient dorsiflexes 1 2RT Check the checkbox to show the 1 2RT half recovery time values on the screen ...

Страница 26: ...ck one of Monitoring buttons or waveform windows to start monitoring the waveform 5 When patient is ready click Start Test button to start venous reflux study 6 Ask patient to flex his foot synchronizing with beep sound as many as count number being set on the settings Click Cancel to cancel testing if necessary When an appropriate waveform returns to the base line amplitude it will automatically ...

Страница 27: ...ting 2 Click Foot Temperature launcher icon on Main Screen 3 Click Settings button on Foot Temperature screen and set the settings as follows Unit Select either Celsius C or Fahrenheit F for temperature unit Extra temperatures Check the checkbox to show extra temperature boxes on the screen Note Site name for each extra temperature box can be changed by typing in Click Save to set all the settings...

Страница 28: ...mperature OR click the box where you wish to measure for 5 Repeat steps 3 to 4 for the next site until all testing is completed Note After using temperature probe wipe the probe using with a soft dry cloth Take great care that any water may not penetrate into the probe Typing foot temperatures 1 Click the temperature box where you wish to type one in taken by an external thermometer and it will tu...

Страница 29: ...ata Note If the check box of Export to DICOM on Option Screen is being checked Smart XT Link will automatically export all the report images of each test module to DICOM 5 2 Search Files 1 Click Search Files on Main Screen to open Search Files screen and it will show Smart XT Link data files stored on the data folder specified on Option Screen Default C Hadeco SXTLink6_1 0 WaveData 2 Select the fi...

Страница 30: ...ck Delete to proceed Advanced operation a Folders pane and files pane can be resized by dragging the splitter bar between the 2 panes Columns in files pane can also be resized b Click the column name to sort files alphabetically and click it the second time to sort anti alphabetically c Right click on folder in folders pane to show a context menu of Rename Delete folder and New folder and select t...

Страница 31: ...w or PDF to create PDF report file 5 5 Patient Information See the section 4 1 Starting operation 5 6 Symptoms Diagnosis 1 Check the appropriate check boxes and type information in text boxes and then click Save to proceed Note Other 1 to Other 3 can be overtyped with your own word for Diagnosed Conditions if desired 1 To open these screens on the testing screen click Patient information Symptoms ...

Страница 32: ...Change to revise Select the data and click Delete to delete it 2 Click Save to proceed when the data have been typed 5 8 Option Screen a CommPort Setting Turn on the unit and connect it to computer Go to Option Screen and click Search Comm to search COM port connected to the unit COM port number will be shown next to Search Comm when it s been found b Language Select Select your language from the ...

Страница 33: ...COM files should be exported e Auto Power Off To activate the auto power off capability and the unit will be automatically shut off when it is left on without AC adaptor connected and the auto off time selected from pull down menu passes This box is checked as default settings f Gain Unification Check it to unify all the amplitude scales of waveforms in each testing module g Auto file save Check i...

Страница 34: ...rom the probe Clean the probe using damp cloth and then wipe with a soft dry cloth but take great care that any water may not penetrate into the probe MAIN UNIT To clean the main unit use a damp cloth and then wipe with a soft dry cloth but take great care that any water may not penetrate into the unit CUFFS The cuffs are intended for use only on intact skin To clean them wipe away any dirt or sta...

Страница 35: ...erved to avoid damage to the unit Refer the operating manual carefully 7 2 Contents of package Main unit 1 Smart XT Link for 6 ports CD ROM 1 USB cable USB CB5 1 Operating manual 1 Tubing 6 AC adaptor DPS54 M 1 Power cable 1 PPG probe PG 01 2 PPG probe holder 2 PPG probe clip 2 How to use the PPG probe holder 1 Attach the holder to the flat place on the main unit with double sided tape 2 Put PPG t...

Страница 36: ...and is converted into electric signals again The converted signals are amplified and then detected After removing unnecessary noise from the signals and improving S N ratio at the filter circuit the Doppler shift signals are amplified and are converted to audible sounds through a speaker Simultaneously the Doppler shift signals are applied to the CPU and converted to blood flow velocity waveform s...

Страница 37: ...t and determines the systolic pressure based on oscillometry algorithm Photoplethysmography While taking toe pressure with PPG probe as well as performing PPG venous reflux study the unit senses the reflection of light from the hemoglobin of the red blood cells in surface vessels by utilizing infrared light with the probe Pneumoplethysmography PV While performing PV waveform test for toes and legs...

Страница 38: ...ure probe USB PPG PV 2 Pressure sensor Inflation pump Exhaust valve Cuff selector circuit D A Inflation control circuit Cuff selector circuit D A PPG PPG PPG PV 1 PPG Probe PPG Probe Temperature probe AC adaptor PPG PV Sound Temperature Probe Inflation pump Pressure control circuit Pressure sensor Exhaust valve Charging LED Sound circuit Doppler Sound Doppler Probe Transducer High frequency circui...

Страница 39: ...r 30 to 260 mmHg Heart rate Oscillometry 30 to 200 BPM Doppler 30 to 240 BPM Accuracy Blood pressure Oscillometry 5 mmHg PPG Doppler 5 mmHg Heart rate 5 Temperature 0 5 C Velocity 10 Doppler probe option Frequency Acoustic power Ispta In situ 8MHz 720 mW cm or less Ispta Spatial Peak Temporal Average Intesity Speaker output 250 mW External output USB port Electrical safety Conform to EN60601 1 Int...

Страница 40: ...nvironment specified below The customer or the user of the Smartdop XT should assume that it is used in such an environment Emissions test compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Smartdop XT use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emi...

Страница 41: ...r should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in ...

Страница 42: ... the following symbol NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios ...

Страница 43: ......

Страница 44: ...April 2015 080 00198 1 0 Manufactured by Hadeco Inc 2 7 11 Arima Miyamae ku Kawasaki Kanagawa 216 0003 Japan ...

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