Hadeco Smartdop 30EX Скачать руководство пользователя страница 59

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8-4. Safety standards

The unit confirms to the following standards:

Manufacturing standard: IEC60601-1

(1) Protection class against electric shock

: Class II device

: Internally powered equipment

Protection grade against electric shock : Type BF applied part

(2) Electromagnetic emission and electromagnetic immunity

Guidance and manufacturer

’s declaration – electromagnetic emissions

The Smartdop 30EX is intended for use in the electromagnetic environment specified below. The

customer or the user of the Smartdop 30EX should assume that it is used in such an environment.

Emissions test

compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The Smartdop 30EX 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 emissions

CISPR 11

Class A

The Smartdop 30EX is suitable for use in all

establishments other than domestic, and may be used

connected to the public low-voltage power supply network

that supplies buildings used for domestic purposes

provided the following warning in needed:

Warning: This equipment/system is intended for use by

healthcare professions only. This equipment/system may

cause radio interference or may be necessary to take

mitigation measures, such as re-orienting or relocating the

Smartdop 30EX or shielding the location.

Harmonic

emissions

IEC61000-3-2

Class A

Voltage

fluctuations/ flicker

emissions

IEC61000-3-3

Complies

Guidance and manufacturer

’s declaration – electromagnetic immunity

The Smartdop 30EX is intended for use in the electromagnetic environment specified below. The

customer or the user of the Smartdop 30EX should assure that it is used in such an environment.

Immunity test

IEC60601 test level

Compliance level

Electromagnetic environment -

guidance

Electrostatic

discharge(ESD)

IEC61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete

or ceramic tile. If floors are

converted with synthetic

material, the relative humidity

should be at least 30 %.

Electrical fast

transient/burst

IEC61000-4-4

±2 kV for power supply

lines

±1 kV for input/output

lines

±2 kV for power

supply lines

±1 kV for input/output

lines

Mains power should be that of a

typical commercial or hospital

environment.

Содержание Smartdop 30EX

Страница 1: ......

Страница 2: ......

Страница 3: ... panel 17 3 9 3 OPERATION 18 4 Mode settings 19 4 1 1 Basic Modes 19 4 1 2 Measurement Freeze Mode 19 4 2 Menu mode 20 4 2 1 Menus 20 4 2 2 Menu Operation 21 4 2 3 Menu for Blood Velocity Measurement Mode 22 4 2 4 Menu for Blood Velocity Freeze Mode 22 4 2 5 Menu for Pressure Mode 23 4 2 6 Menu for PV AC Mode 23 4 2 7 Menu Mode Details 24 a MEMORY STORE 24 b MEMORY READ 24 c MEMORY CLEAR 25 d DIR ...

Страница 4: ...2 Optional Functions 35 5 2 3 Error Messages 36 5 2 4 Print Samples 36 5 3 PV arterial mode PV AC 37 5 3 1 Waveforms on LCD 37 6 Maintenance 38 6 1 Performance check by user 38 6 2 Cleaning 38 6 3 Warranty 39 7 Options 39 7 1 Probe selection 39 7 2 Others 40 7 3 Photoplethysmograph 40 7 3 1 PPG Photoplethysmography Probe Assemblies 40 7 3 2 PPG Arterial Pulse Waveform Studies 40 7 3 3 PPG Venous R...

Страница 5: ...ce check mentioned in 6 1 Performance check by User 2 Make sure that all cables are connected correctly and safely 3 Using it with other equipment together may cause a misdiagnosis or danger to patient due to a malfunction 4 Double check that all the cables do not obstruct any external connection to the patient 5 Do not sterilize the main unit and non sterilizable probe to prevent any damage 6 Ope...

Страница 6: ...the procedures mentioned in 6 1 Performance Check by User 2 The maintenance must be done at least once a year 10 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 probe body o...

Страница 7: ... Destruction 1 In case of destruction of the unit follow the instructions for disposal of the destruction appointed by each country or local government 2 Do not place battery in a fire or it may cause an explosion and injury 17 Any connected computer is not allowed to be in the patient area according to IEC60601 1 ...

Страница 8: ... and prints velocity waveforms in bi directional dual separation channel and numerical data DOPPLER BLOOD PRESSURE RECORDER Full auto system with built in cuff inflator Shows instructions on LCD for measuring pressures if desired Calculates and prints ABI TBI and velocity pressure documentation TWO PROBE COMBINATIONS for 2 4 5 8 10 MHz PPG and PV The unit has dual probe connectors and selection sw...

Страница 9: ...BI studies Bi directional lower extremity studies PEAK MEAN blood velocity determinations Peripheral vascular procedures Blood pressure segmental studies Venous compressions Penile digit systolic pressures Toe pressure venous reflux studies PPG PV Arterial studies Note The Smartdop 30EX and associated Doppler probes inflatable cuffs and optional photoplethysmography probe are not intended for use ...

Страница 10: ...4 MHz Deep peripheral blood velocity and flow BT5M05S8C 5 MHz Deep peripheral blood velocity and flow BT8M05S8C 8 MHz Superficial blood velocity and flow BT10M5S8C 10 MHz Superficial blood velocity and flow Note One of these probes comes with Smartdop as a standard component Other probes are available as optional components 1 4 Contents in package Main unit 1 Probe 1 AC adaptor GMPU18UI 3 1 Ultras...

Страница 11: ...ume 4 Probe holder 2 For probe placement when not in use Probe holder 2 can be removed by removing the 2 screws Fix them to the unit 5 Probe holder 1 For probe placement when not in use 6 Probe connector 1 To connect probe 1 7 Headset To connect headset It cuts off the speaker 8 Inflation inlet To connect the tubing for the blood pressure cuff 9 LCD display Displays waveform numerical data and men...

Страница 12: ...s respectively 12 PRINT button To activate and deactivate the printer Menu mode To move the cursor up 13 MENU button To go to menu mode See 4 2 Menu Mode for details To turn backlight on off 14 Probe selection button To select the probe intended to use from the connected probes The LED corresponding to the probe number will illuminate To select PV Arterial mode and both of LED will illuminate When...

Страница 13: ...pressing longer than 2 sec Measurement mode To magnify the view of waveform Measuring blood velocity To change the Display mode Waveform Numerical data Menu mode To move the cursor down 17 ARM button Measuring pressure To store and display the measured pressure value as an arm brachial pressure Freeze mode To display ABI or TBI Measurement mode To erase measured pressure data by pressing longer th...

Страница 14: ...ted AC adaptor 22 Power switch To turn on off the unit 23 Probe Multi probe selection of 2 4 5 8 and 10 MHz 24 Probe button To freeze and unfreeze the waveform To activate and deactivate cuff inflator Note The function is defined in the menu PRB KEY See 4 2 7 l OTHERS PRB KEY for details 25 Probe cap To protect the probe transducer tip when probe is not in use 24 25 23 18 19 20 21 22 ON OFF ...

Страница 15: ... right The unit can be used for a few more minutes however we recommend recharging battery as soon as possible for further use AUTOMATIC SHUT OFF When the AUTO OFF is ON if the unit is left on without AC adaptor connected the power is automatically shut off after following time passes a 5 minutes when no signal b 15 minutes when on measurement c 10 minutes when on freeze mode Note If automatic shu...

Страница 16: ...tery Using and charging the battery repeatedly without fully discharging may cause a shorter full charge battery life Fully discharge battery before charging every once in a while See 4 2 7 q OTHERS DISCHARGE how to do it 3 3 Checking battery level Battery level indicator shows upper right of the menu screen 1 Turn the unit on and press MENU button to display the menu When battery is low low batte...

Страница 17: ... before inserting the paper for loading it easily Apply slight fingertip pressure to the paper at beginning of insertion Caution Do not pull paper in a direction opposite to the direction of paper feed printing and auto loading It may cause malfunction of the printer In cases removing paper from printer cut the paper at the roll side and pull the remaining paper out in the direction of paper feed ...

Страница 18: ...ss probe selection button to change it 4 Press MODE button to select Mode 1 for arteries or Mode 2 for veins 5 Put the probe on the measurement area and move it slowly to locate the point where the maximum Doppler sounds are heard An ideal probe angle to the vessel is approximately 45 to 60 degrees Wait more than 5 sec for MODE 1 OR up to 25 sec for MODE 2 without moving probe after the maximum Do...

Страница 19: ... connector 1 or 2 See the step 1 in the 3 1 Turning the unit ON for the details 3 Turn the unit on and make sure the probe selection LED illuminating corresponds to the connector you connected probe If not press probe selection button to change it Press MODE button to select ARM LEG pressure mode ARM LEG LED will illuminate Taking Arm pressure 4 Wrap the cuff above the elbow and apply the probe to...

Страница 20: ...or message is displayed in the inflation and deflation processes press any button other than probe selection button to delete the error message and go back to step 5 The LCD will show the systolic pressure when the first Doppler sound is heard and then the cuff pressure will be dumped automatically Press and hold MODE button and press Down LEG TOE to get on MAGNIFIED waveform mode if desired Do it...

Страница 21: ...ure 10 Take the ankle pressure the same way for the brachial Steps 5 to 6 of this section Press the LEG TOE button to store it as the ankle pressure and the ABI will be displayed as shown in the right 11 Go to the next ankle pressure on the other side Note Press the ARM or LEG TOE button more than 2 sec to clear the pressure data for the next patient ...

Страница 22: ... Connect PPG probe to the probe connector 2 with the round polarity mark up on the probe connector 12 o clock 5 Press probe selection button to select probe 2 6 Wrap the cuff around the base of the big toe and affix the PPG probe to the pad of the toe with Velcro strap 7 Take the toe pressure the same way for the brachial Press the LEG TOE button to store it as the toe pressure and the TBI will be...

Страница 23: ...e the cuff up to 60 mmHg automatically Note Press INF DUMP button to stop the inflation and dump cuff while inflation is in progress if desired The gain is automatically adjusted and the PV waveform is shown on the LCD 5 When the waveform gets stable and rhythmic press INF DUMP Freeze to freeze the waveform and to dump the cuff Press PRINT button to print the waveform of last 5 sec if necessary 6 ...

Страница 24: ...rate is not stable the asterisk will show above HR 3 9 2 Operating panel 1 MENU To go to menu mode 2 Probe selection button To select the probe intended to use from the connected probes 3 FREEZE RIGHT To freeze heart rate Pressing probe button also freezes it To fix the mode or change the setting on menu mode 4 UP DOWN To move the cursor up down on menu mode 5 LEFT To get out of menu mode Other bu...

Страница 25: ...nds to the connector you connected probe If not press probe selection button to change it 4 Put the probe on the middle of the abdomen at right angle to the skin surface and move it slowly to locate the point where the maximum heart beat Doppler sounds are heard Caution Verify the fetal heart rate Maternal heart sates match the maternal pulse rates 5 When the heart rate becomes stable press the pr...

Страница 26: ...terial mode press Probe Selection button a few times until both LEDs on the button illuminate Press MENU button to go to menu mode and MENU LED on the button will illuminate 4 1 2 Measurement Freeze Mode Press Freeze button or probe button to freeze or unfreeze the waveform Measurement mode For measurement Unfreeze Freeze mode For observing waveforms and numerical data Note1 On Freeze mode followi...

Страница 27: ...nu mode Some menus have sub menus Refer to following Menus and Menu operation first 4 2 1 Menus Menu Submenu Blood Velocity measurement mode Blood Velocity freeze mode ARM LEG TOE measurement mode ARM LEG TOE freeze mode PV AC measurement mode PV AC freeze mode ...

Страница 28: ...tting Note On menu mode some of the buttons on operation panel work as cursor buttons as follows PRINT Up ARM Left LEG TOE Down INF DUMP Right Probe selection Enter 3 For MEMORY and OTHERS modes press Enter or Right to display sub menu and Up and Down to select each sub menu 4 For MEMORY submenu press Enter or Right to show the memory number and press Up and Down to change the number 5 Press Left ...

Страница 29: ...od Velocity Measurement Mode Note 1 DISCHARGE is available when AC adaptor is connected to the main unit 4 2 4 Menu for Blood Velocity Freeze Mode Note 1 DISCHARGE is available when AC adaptor is connected to the main unit ...

Страница 30: ...STORE is available only when on Freeze mode and pressure s has been assigned to ARM or LEG TOE 4 DISCHARGE is available when AC adaptor is connected to the main unit 4 2 6 Menu for PV AC Mode Note 1 WAVEFORM is available only on Freeze mode 2 STORE is available only on Freeze mode 3 DISCHARGE is available when AC adaptor is connected to the main unit ...

Страница 31: ...isplay automatically Note If other data have been already stored in memory number storing a confirmation of OVERWRITE will be shown Press Enter to overwrite or press any one of cursor buttons to cancel for selecting other memory number available STORE sub menu is not available if pressure has not been assigned to ARM or LEG TOE b MEMORY READ 1 Select the memory number where to read waveform data f...

Страница 32: ...you wish to clear press Up and Down to select other memory 3 To clear all the data at once except FREEZE select and press on ALL and follow the instruction d DIR Flow direction Press Right to change waveform polarity as follows Forward Flow toward probe is processed as positive component Reverse Flow away from probe is processed as positive component e DISP OTHERS DISP Waveform Data Press Right to...

Страница 33: ...form Press Right to change viewing area of waveform FULL Full waveform is displayed on LCD MAGNIFIED Magnified waveform where systolic pressure has been determined is displayed on LCD Note FULL MAGNIFIED mode can be also changed by pressing a key combination of MODE Down when on pressure freeze mode g GUIDANCE This setting enables or disables the function of displaying guidance on the LCD while on...

Страница 34: ...move cursor to the right and the left for locating the true systolic pressure point 3 Press Enter to fix it or press Menu to cancel Note Adjusting systolic point can be also done by pressing a key combination of MODE Right Left j P DISP Displaying erasing Pressure value Press Enter or Right to display pressure waveform WITH or WITHOUT pressure value s Note The Pressure Display mode can be also swi...

Страница 35: ...ts 4 step 3 2 1 0 1kHz calibration after velocity waveform on the chart OFF Prints no calibration waveform o OTHERS BACKLIGHT LCD backlighting time can be adjusted on BACKLIGHT setting and the longer time gives you shorter battery life Press Up and Down to select the time and press Enter to fix it ON Turns backlight always on OFF Turns backlight always off 10 60 Auto off time with 10 sec steps Not...

Страница 36: ...f See 3 1 Turning the Unit On for the details q OTHERS DISCHARGE DISCHARGE is available when AC adaptor is connected to Smartdop 1 Press Enter and confirmation START will be shown 2 Press Enter again to start discharging and then charging Note It takes a few extra hours to fully discharge a fully charged battery prior to full charging hours ...

Страница 37: ...computer 2 Connect Smartdop to the computer with dedicated communication cable that comes with Smart V Link 3 Turn the unit on and start Smart V Link on your computer Note Refer to the operating manual for Smart V Link for details Shortcut keys Functions Modes Reference in 4 2 7 MODE MENU Backlight On Off All modes o Others Backlight MODE RIGHT Right Cursor Pressure i Cursor MODE LEFT Left Cursor ...

Страница 38: ...n USB connector Print button AC adaptor connector Menu button Probe connector Arm button Caution Refer to the Operating manual Leg Toe button Power ON Probe selection button Power OFF Probe button Manufacturer Note Caution must be observed to avoid damage to the unit Refer the operating manual carefully ...

Страница 39: ...approx 5 mm sec Forward component arterial is separated from reverse component venous For typical operation for blood velocity modes see 3 5 Measuring Blood Velocity 5 1 1 Waveforms on LCD The base line is automatically located at best position depending on how big the reverse component is Smartdop has 4 base lines the bottom 1 4 from the bottom the center and 3 4 from the bottom The waveform ampl...

Страница 40: ... will be printed out as an error indicator 5 1 3 Printing Waveform and Numerical Data 1 Press PRINT button to print waveforms Also pressing probe button controls printer when PRB KEY in the menu is set for PRINT or FRZ PRINT mode 2 Smartdop prints waveforms and numerical data as follows and then stops printing automatically Measurement mode Mode 1 Waveform of the last 5 sec before pressing PRINT b...

Страница 41: ...34 5 1 4 Print Samples Mode 1 Artery Time scale 0 2 sec div approx 25 mm sec Mode 2 Vein Time scale 1 sec div approx 5 mm sec 0 2 sec 5 sec max 1 sec 25 sec max ...

Страница 42: ...sure modes see 3 6 Ankle brachial pressure index ABI and 3 7 Toe brachial pressure index TBI 5 2 1 Display Samples in Pressure Measurement Process 1 During measurement for blood pressure of arm 2 End of the measurement for arm pressure Freeze mode 3 After pressing ARM button 4 After measurement of leg pressure and pressing LEG button 5 2 2 Optional Functions Press ARM or LEG TOE button to recalcul...

Страница 43: ...E6 Cuff pressure don t go up E7 Cuff pressure don t go down E9 Cuff pressure go up very fast Press any button other than probe selection button to delete the error message and proceed to next step 5 2 4 Print Samples 1 Pressing PRINT button less than 1 sec 2 Pressing PRINT button longer than 2 sec ARM only LEG only TOE only ARM and LEG ARM and TOE Arm Leg and Toe Arm should be saved at the end Pre...

Страница 44: ...veform per screen of LCD Prints waveform in time scale of approx 25 mm sec For typical operation for PV AC mode see 3 8 PV Arterial Studies 5 3 1 Waveforms on LCD The waveform amplitude is automatically adjusted for optimal observation The pressure amplitude scale per division is shown at top left of LCD Pulse volume amplitude and heart rate are shown at bottom of LCD Amplitude scale Pulse volume ...

Страница 45: ...if sounds come out from speaker and LCD shows the waveform 6 Check if sound volume can be adjusted 7 Check if battery level is sufficient for battery operation 6 2 Cleaning Probe Remove the Doppler gel from the probe head after use 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 If using disinfectant consult i...

Страница 46: ...s over please consult your dealer for a charged service 7 Options 7 1 Probe selection The frequency of diagnostic ultrasound is inversely proportional to depth of penetration Use those probes depending on your applications Standard Doppler probe Standard 2MHz BT2M20S8C A 4MHz BT4M05S8C A 5MHz BT5M05S8C A 8MHz BT8M05S8C A 10MHz BT10M5S8C A Flat 8MHz BF8M15S8A The end word C indicates curl type cabl...

Страница 47: ... Photoplethysmography Probe Assemblies Model PG 21 AC Coupling Arterial pulse waveform studies Toe pressure DC Coupling Venous reflux study 7 3 2 PPG Arterial Pulse Waveform Studies Purpose Arterial pulse waveform studies by photoplethysmography are performed to determine the presence or absence of pulsatile flow and to assess the state of perfusion in the tissue area immediately beneath the senso...

Страница 48: ...e sensor with the clear side against the skin surface and fix it in place using Velcro strap or double sided clear tape or PPG probe clip Option 2 The gain is automatically adjusted and the PPG waveform is shown on the LCD 3 When the waveform gets stable and rhythmic press INF DUMP or probe button to freeze the waveform Press PRINT button to print the waveform of last 5 sec if necessary Note When ...

Страница 49: ...kin surface of the lower limb is warm Cold constricts superficial blood vessels and thus jeopardizes the accuracy of PPG measurements Examination Procedure 1 Have the patient sit on an examination table so that the feet are off the floor 2 Apply the sensor with the clear side against the skin surface to the medial malleolus over the posterior tibial vein Fix the sensor in place with double sided c...

Страница 50: ...recovery times Note 1 2 is the half recovery time for returning to 50 of refilling amplitude where middle vertical dotted line is shown Interpretation Normal RT 20 sec 1 2RT 7 sec 7 If you wish to save the data on the memory see 4 2 7 a MEMORY STORE 8 Press the INF DUMP or probe button to get out of the freeze mode Note When PRB KEY is on Freeze mode ...

Страница 51: ...surement mode 3 MEMORY STORE is available only on Freeze mode 4 DISCHARGE is available when AC adaptor is connected to the main unit 7 3 5 PPG Mode Settings MODE AC DC Only available in Measurement mode 1 Press MODE button to select the mode Mode LED corresponding to the mode will illuminate Mode 1 AC coupling mode for arterial pulse waveform studies Mode 2 DC coupling mode for venous reflux study...

Страница 52: ...s of presenting signs and symptoms pain and swelling being frequently due to other causes objective screening tests are of value in confirming or ruling out suspected venous obstructions in the lower extremities The test consists of first inducing temporary venous pooling by means of a constricting thigh cuff followed by measurement of the rapidity of emptying when the constricting cuff is suddenl...

Страница 53: ... Turn the stopcock so that it blocks sphyg and routes cuff pressure to the PV probe 7 Disconnect the sphyg from the stopcock and attach it to the occluding cuff at the thigh If INFLATOR is ON connect occluding cuff to inflation inlet of Smartdop instead of sphyg with a tubing 8 Press PRINT button to begin the measurement process 9 Inflate the occluding cuff at the thigh to at least 60 mmHg If INFL...

Страница 54: ...s AUTO OFF DISCHARGE q Others Discharge Note 1 INFLATOR is available only on Measurement mode 2 MEMORY STORE is available only on Freeze mode 3 DISCHARGE is available when AC adaptor is connected to the main unit 7 4 4 PV Mode Setting MODE AC DC Only Measurement mode 1 Press MODE button to select the mode Mode LED corresponding to the mode will illuminate Mode 1 AC coupling mode for arterial pulse...

Страница 55: ... or a headset Simultaneously the Doppler shift signals are applied to the CPU and converted to blood flow velocity waveform signals which can be displayed and printed On the ARM LEG and TOE pressure modes the blood pressure cuff is wrapped where the blood pressure is taken and the probe is put on the lower extremity artery by the operator Before the inflation the peak amplitudes of the blood flow ...

Страница 56: ...49 8 2 Block diagram ...

Страница 57: ...inting Battery life Approx 2 years 300 full charges Automatic shut off No signal 5 min Freeze 10 min Others 15 min Frequency range 200 Hz to 5 kHz Mode settings Operation Display Direction Memory Others Waveform memory 30 waveforms LCD display 128 x 64 dots STN LCD Bi directional blood velocity waveform Numerical data Systolic mean velocities HR Heart rate 30 to 240 BPM Blood pressure data pressur...

Страница 58: ...orage and transport environment 0 to 50 degrees Centigrade 85 humidity or less with no condensation Dimensions Main unit 252 W x 192 D x 91 H mm Probe holders not included Probe 20 Diam x 105 L mm Weight Approx 1 6 kg including 1 probe Manufacturing date The first 2 digits and following 2 digits of the serial number represent the year and month of manufacturing respectively Examples 03020001 Feb 2...

Страница 59: ...uildings used for domestic purposes provided the following warning in needed Warning This equipment system is intended for use by healthcare professions only This equipment system may cause radio interference or may be necessary to take mitigation measures such as re orienting or relocating the Smartdop 30EX or shielding the location Harmonic emissions IEC61000 3 2 Class A Voltage fluctuations fli...

Страница 60: ...age prior to application of the test revel Guidance and manufacturer s declaration electromagnetic immunity The Smartdop 30EX is intended for use in the electromagnetic environment specified below The customer or the user of the Smartdop 30EX should assure that it is used in such an environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC...

Страница 61: ...base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Smartdop 30EX is used exceeds the ap...

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Страница 64: ...Manufactured by Hadeco Inc 2 7 11 Arima Miyamae ku Kawasaki Kanagawa 216 0003 Japan September 2017 Printed in Japan 080 00114 2 6 ...

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