OPERATING MANUAL

Smartdop 30EX BI-DIRECTIONAL BLOOD FLOWMETER With BLOOD PRESSURE RECORDER

Excellence in Human Service and Technology

Hadeco, Inc.

SD30EX OM E-10 April, 2007

TABLE OF CONTENTS Cautions 1.

Introduction 1-1. Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2. Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3. Probe Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 3 4 4

2.

Quick Start 2-1. Turning the Unit On / Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2-2. Charging / Discharging Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2-3. Checking Battery Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2-4. Setting Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2-5. Measuring Blood Velocity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2-6. Ankle Brachial Pressure Index (ABI) . . . . . . . . . . . . . . . . . . . . . . . 11 2-7. Toe Brachial Pressure Index (TBI) . . . . . . . . . . . . . . . . . . . . . . . . 14

3.

Appearance and Mode Settings 3-1. Operating Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2. Mode and Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2-1. Basic Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2-2. Changing Modes with Operation Buttons . . . . . . . . . . . . . . . 3-2-3. Menu Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a. Menu table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b. Menu operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2-4. Menu Mode Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a. MEMORY - STORE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b. MEMORY - READ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c. MEMORY - CLEAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d. LANGUAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e. PRG-KEY (Probe button function) . . . . . . . . . . . . . . . . . . f. GUIDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . g. CALibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3. LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3-1. Blood Velocity Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3-2. Pressure Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3-3. Battery Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4. Printing Waveforms & Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5. External Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6. Symbol List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18 23 23 23 25 25 26 27 27 28 28 29 29 30 30 31 31 32 34 35 40 41

4.

Maintenance 4-1. Performance Check Procedures by User . . . . . . . . . . . . . . . . . . . 42 4-2. Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 4-3. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.

Options 5-1. Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2. Photoplethysmograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2-1. PPG (Photoplethysmography) Probe Assemblies . . . . . . . . 5-2-2. Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2-3. PPG - Arterial Pulse Waveform Studies . . . . . . . . . . . . . . . . 5-2-4. PPG - Venous Reflux Study . . . . . . . . . . . . . . . . . . . . . . . . . 5-2-5. Menu for PPG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2-6. PPG Mode Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3. Pneumoplethysmograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3-1. PV (Pneumoplethysmography) Probe Assemblies . . . . . . . . 5-3-2. Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3-3. PV - Arterial Pulse Waveform Studies . . . . . . . . . . . . . . . . . . 5-3-4. PV - Measurement of Maximum Venous Outflow . . . . . . . . . 5-3-5. Menu for PV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3-6. PV Mode Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44 44 45 45 45 48 51 51 52 52 53 53 55 58 58

Technical Information 6-1. Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2. Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4. Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

59 61 62 64

6.

CAUTIONS Please read the following important points carefully before you operate the unit.

1. Only skilled persons should operate the unit. 2. Use the unit for blood flow measurement purposes only. 3. Do not apply any modification to the unit. 4. Unit installation: (1) Take care of storage and operating environments. (2) Do not place near water. (3) Dot not place where atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, salt, sulfur and so forth will not affect the unit adversely. (4) Take care of the stability conditions such as inclination, vibration, and shock during transportation and installation works. (5) Do not place where chemicals are stored, or where gas may be generated. (6) Do not place where the unit tends to fall. 5. Before use: (1) Make sure that the unit operates safely and correctly by following the maintenance procedures mentioned in "§ 4-1. Performance Check Procedures by User". (2) Make sure that all cables are connected correctly and safely. (3) Using more then one equipment together may result in erroneous diagnosis from malfunction or cause a danger. (4) Recheck external connections to the patient carefully. (5) Do not sterilize the main unit by gas, autoclave or so on to prevent any damage. 6. Operation: (1) Do not use the unit simultaneously with an electric cautery, cardioverter,

(2) (3) (4)

(5)

(6) (7) (8) (9) (10)

other ultrasonic device or mobile phone. Be careful not to exceed time and volume which is necessary for diagnosis treatment. Always watch so the unit and patient are not under abnormal conditions. When any abnormality is found on the unit or the patient, take proper action such as stopping operating the unit in a manner safe to the patient. In case of emergency or unexpected, take the following action(s) to stop the inflation of the cuff: • Press INF/DUMP button. • Disconnect the tubing from the unit. • Turn the unit off. Do not let the patient touch the unit. Use the designated accessories only such as the probe. Do not use the accessories with other devices. Use the unit under the operating environments specified on the specifications. Use the Smartdop as specified in the operation manual.

7. After use: (1) Return all switches to the conditions before use and turn off the power supply following the prescribed procedures. (2) Do not apply excessive force to disconnect the cables such as pulling them too strongly. (3) Clean the unit, accessories, cables and probes and place in right place for the next use. 8. Storage: (1) Take care of (1) to (5) of section #4 in the previous page. (2) Clean the unit, accessories, cables and probes and place in right place for the next use. (3) When using the unit next time, follow the maintenance procedures to make sure it works properly and safely. 9. Do the periodical inspection by following the procedures mentioned in "§ 4-

1. Performance Check Procedures by User". (1) Inspection must be done once a year. 10. Probes: (1) Clean the probe using damp cloth or a recommended probe cleaner before use. Using alcohol or thinner may damage the probe (2) The probe transducer tip is very thin and delicate. Please handle with care and use the probe cap when not in use. 11. Ultrasonic gel: (1) Use ultrasonic gel only for non-invasive use. Using other materials such as baby oil and cream may cause incorrect Doppler sounds. (2) Using other materials may damage the probe. (3) The ultrasonic gel enclosed is non-sterile and do not use it for surgeries. (4) Incidence of allergy: Discontinue use of gel if an allergic reaction occurs. 12. Battery: (1) When battery is extremely low, the LCD display will not operate. Also there will be no speaker sounds. Charge the battery. (2) Battery life is 300 full charges. When full charging life is obviously short, contact your dealer for replacing battery. 13. Repair services: (1) When the unit gets out of order, contact the dealer for repair from whom you purchased the unit. (2) Only authorized persons should perform the repair services. 14. Do not disassemble the Smartdop. 15. Destruction: (1) In case of destruction of the unit, follow the instructions for disposition of the destruction appointed by each country or local government. 16. Any connected computer is not allowed to be in the patient area according to IEC60601-1.

Ω°•®

1. INTRODUCTION Thank you very much for choosing the Smartdop 30EX. The Hadeco Smartdop 30EX is a uniquely designed bi-directional handheld Doppler with LCD display and Doppler blood pressure monitor capability. It detects arterial and venous blood flows in extremities as well as blood pressures of brachial, ankle and toe, and calculates ABI and TBI automatically. Please read this manual carefully to acquaint yourself with the Smartdop operation. This medical device can be used by doctor for the purposes mentioned in "§ 1-2. CLINICAL APPLICATIONS" for patient in hospital and clinic. For the use with computer, refer to the operating manual for Windows linking software optional.

1-1. FEATURES *

BI-DIRECTIONAL DOPPLER WITH LCD DISPLAY and PRINTER Displays 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. Calculates and prints ABI /TBI and velocity/pressure documentation.

1

Introduction *

Features

TWO PROBE COMBINATION (4, 5, 8, 10 MHz, PPG and PV) Smartdop has dual probe connectors and selection switch. Convenient for measuring pressures for TBI

*

30 WAVEFORM MEMORY Smartdop stores waveforms and numerical data of Doppler, pressures and PPG/PV.

*

CONVENIENT PROBE ACTIVATION BUTTON Freezes waveform. Activates and deactivates the printer as well as the PRINT button. Inflates and dump the cuff as well as the INF/DUMP button. The function depends on probe key mode setting, PRB-KEY.

*

AUTOMATIC SHUT-OFF

*

USB COMPUTER INTERFACE Transfers waveforms and numerical data to computer for data storage. Communication cable and Windows software are optional.

*

Photoplethysmograph (PPG) and Pneumoplethysmograph (PV) PROBES OPTIONAL Expands arterial & venous testing.

2

Introduction

Clinical Applications

1-2. CLINICAL APPLICATIONS Detections of arterial and venous blood flow velocity and pressures * ABI and TBI 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). NOTES: (1) Although the derated acoustic intensity of all probes is sufficiently low so that no known obstetric safety hazard exists, the Smartdop 30EX is not recommended for fetal use because the available frequencies are not optimal for fetal heart detection and the probe diameter is too small for efficient transabdominal detection of maternal and fetal vessels. However, there is no restriction on performing peripheral vascular studies on pregnant patients when indicated. (2) The Smartdop 30EX and associated Doppler probes, inflatable cuffs, and optional photoplethysmography probe are not intended for use in contact with blood or mucous membranes.

CONTRAINDICATIONS Do not use the Smartdop 30EX for ophthalmic or periorbital studies as the acoustic intensity is higher than the level recommended by authorities for use on and around the eye.

3

Introduction

Probe Selection / Accessories

1-3. PROBE SELECTION The frequency of diagnostic ultrasound is inversely proportional to depth of penetration. The Smartdop has 4 interchangeable probes with different frequencies. Use those probes depending on your applications. Note: One of these probes comes with Smartdop 30EX as a standard accessory. Other probes are available as optional accessories. BT4M05S8C (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: The above-listed probes are intended only for transcutaneous use. For information on probes for intraoperative or laparoscopic applications, please contact the dealer.

1-4. ACCESSORIES Probe with a cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

AC adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

Ultrasonic gel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

Headset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood pressure cuff (VC-12). . . . . . . . . . . . . . . . . . . . . . . .

1 1

Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

4

2. QUICK START For the first time of use and in case the unit has not been used for a while, fully charge the internal battery.

2-1. TURNING THE UNIT ON (1) Connect the probe with round polarity mark up (12 o'clock) on the probe connector and turn the unit ON.

Polarity mark

Power ON : Power OFF :

Power switch

(2) When battery is low, low battery indicator appears as shown right. You can use Smartdop for some time however, we strongly recommend recharging battery as soon as possible for further use. Low battery indicator

5

Quick Start

Charging / Discharging Battery

(3) AUTOMATIC POWER OFF If the unit is left on without AC adaptor connected, the power is automatically shut off after following time passes: (a) 15 minutes when in measurement. (b) 5 minutes when no signal. (c) 10 minutes when on freeze mode.

2-2. CHARGING / DISCHARGING BATTERY (1) Turn the unit off and plug the AC adaptor to the unit to charge battery. The MODE LEDs will illuminate sequentially (one after another) while charging is in progress. Note: Use the designated adaptor, FRIWO Model #: FW 3299/15.0974 for Europe. (2) When the battery is fully charged, the MODE LEDs will be turned off. Unplug the AC adaptor.

AC adaptor connector

MODE LEDs

(3) Discharging battery When the battery is not fully discharged, charging battery may cause the short charge life of the battery. In this case, we recommend discharging the battery before charging. • Turn the unit off and plug the AC adaptor. • Check if the MODE LEDs illuminate sequentially.

6

Quick Start Charging / Discharging Battery / Checking Battery Level • Press MODE button longer than 2 sec and battery level will be shown. • While holding MODE, press INF/ DUMP to start discharge battery and “DISCHARGE” will be displayed on LCD. • After discharge is completed, “DISCHARGE” will disappear and charge process will start automatically with MODE LEDs flashing on and off. Note: It takes about 4 hours to fully charge battery. Battery life is 300 full charges. Contact your dealer for replacing battery.

2-3. 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. (2) Battery level indicator shows the battery level in 4 steps as shown right. (3) Charge the battery when in low.

7

High

Low

Medium

Empty

Quick Start

Setting Printer Paper

2-4. SETTING PRINTER PAPER (1) Remove the roll shaft and set it into the paper roll. Insert and hold the paper edge into the paper entry under the printer and press the PRINT button. (2) Press the button again when sufficient paper comes out. Pull the paper edge out a few inches and cut it at the paper guide. Put the roll shaft with the paper back on the roller guide. Note: For problem free print paper loading cut the paper straight before inserting the paper. 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 autoloading). It may cause malfunction of the printer. In cases when removing paper from printer, cut the paper at the roll side and pull the remaining paper out in the direction of paper feed. Also paper feed problems like paper jam or wrinkled paper hit by printer head or something may cause malfunction of the printer. Insert paper correctly according to the above mentioned instructions.

8

Quick Start

Measuring Blood Velocity

2-5. MEASURING BLOOD VELOCITY This section explains the fundamental use of measuring blood velocity. Refer to “§ 3. Appearance and Mode Settings” for various uses. Polarity mark

(1) Connect the probe to the probe connector #1 or 2 of the Smartdop with the round polarity mark up (12 o'clock). (2) Put ultrasonic gel on the probe top or patient skin.

Probe connector #1

Power switch

(3) Turn the unit on and turn the volume control to maximum. Make sure the probe selection LED illuminating corresponds to the connector you connected probe with. If not, press probe selection button to change it.

Probe connector #2

(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.

9

Quick Start

Measuring Blood Velocity (6) Wait more than 5 sec for MODE 1 (OR up to 25 sec for MODE 2) without moving probe after the maximum Doppler sounds, press probe button* (or INF/DUMP button) to freeze the waveform. Press PRINT button to print the waveform of last 5/25 sec, if necessary. Note: * Probe button function can be selected from Freeze, Print, and Freeze & Print on PRB-KEY mode setting. (7) Headset can be used to listen to Doppler sounds. It will cut off the speaker.

Headset connector

(8) If you wish to save the waveform and numerical data on the memory, see “§ 3-24-a. MEMORY - STORE”.

(9) Press INF/DUMP button or probe button* to get out of the freeze mode.

10

Quick Start

Ankle Brachial Pressure Index

2-6. ANKLE BRACHIAL PRESSURE INDEX (ABI) (1) Connect the cuff VC-12 to the tubing and other end of tubing to the inflation inlet as shown in picture left.

Inflation inlet Polarity mark

Probe connector #1

(2) Connect the probe to the probe connector #1 or 2 of the Smartdop with the round polarity mark up on the probe connector (12 o'clock). (3) Turn the unit on and make sure the probe selection LED illuminating corresponds to the connector you connected probe with. If not, press probe selection button to change it. Press MODE button to select ARM/LEG pressure mode. (ARM/LEG LED will illuminate.) (4) Wrap the cuff above the elbow and apply the probe to the radial or brachial artery at an angle of approximately 45 to 60 degrees.

11

Quick Start

Ankle Brachial Pressure Index (5) Move the probe slowly to locate the point where the maximum Doppler sounds are heard and the INF/DUMP LED will blink after a few seconds. Note: Once you locate the point, please keep the probe there until blood pressure is taken. In case INF/DUMP LED doesn't blink due to low flow or arrhythmia, press INF/DUMP button longer than 2 sec to activate cuff inflator manually in the next step #6. (6) Press INF/DUMP or probe button to inflate the cuff. The unit will stop the inflation at estimated 20 mmHg above the sound cessation and deflate the cuff at 3 to 4 mmHg/sec automatically. Note: In case the inflation didn't stop automatically, press INF/DUMP (Probe) button the second time to stop the inflation. Press it again to dump the cuff if necessary. If an error 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.

12

Quick Start

Ankle Brachial Pressure Index (7) The LCD will show the systolic pressure when the first Doppler sound is heard and then the cuff pressure will be dumped automatically.

(8) Press ARM button to store it as the brachial pressure and the LCD will show it as shown in left figure. (9) Press INF/DUMP button to go back to the measurement mode for ankle pressure. (10) Wrap the cuff above the ankle and apply the probe to the posterior tibial artery at an angle of approximately 45 to 60 degrees. (11) Take the ankle pressure the same way for the brachial. (Steps #5 to #7 of this section) Press the LEG/TOE button to store it as the ankle pressure and the ABI will be displayed as shown left. (12) 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 memory for the next patient.

13

Quick Start

Toe Brachial Pressure Index

2-7. TOE BRACHIAL PRESSURE INDEX (TBI) Optional PPG probe (PG-21 or PGV-20) is required for this testing. (1) Connect the cuff VC-12 to the tubing and other end of tubing to the inflation inlet as shown in picture left.

Inflation inlet Polarity mark

(2) Connect the Doppler probe to the probe connector #1 with the round polarity mark up (12 o'clock). Connect the PPG probe to the probe connector #2.

Probe connector #1

Probe connector #2

(3) Turn the unit on and make sure LED #1 on probe selection button illuminates. Press probe selection button to select probe #1 if necessary. Press the MODE button to select ARM/ LEG pressure mode.(ARM/LEG LED will illuminate.)

14

Quick Start

Toe Brachial Pressure Index (4) Wrap the cuff above the elbow and apply the probe to the radial or brachial artery at an angle of approximately 45 to 60 degrees. Note: To delete this instruction and proceed to the next, press any button other than probe selection button. (5) Move the probe slowly to locate the point where the maximum Doppler sounds are heard and the INF/DUMP LED will blink after a few seconds. Note: Once you locate the point, please keep the probe there until blood pressure is taken. In case INF/DUMP LED doesn't blink due to low flow or arrhythmia, press INF/DUMP button longer than 2 sec to activate cuff inflator manually in the next step #6. (6) Press INF/DUMP or probe button to inflate the cuff. The unit will stop the inflation at estimated 20 mmHg above the sound cessation and deflate the cuff at 3 to 4 mmHg/sec automatically. Note: In case the inflation didn't stop automatically, press INF/DUMP (Probe) button the second time to stop the inflation. Press it again to dump the cuff if necessary.

15

Quick Start

Toe Brachial Pressure Index (7) The LCD will show the systolic pressure when the first Doppler sound is heard and then the cuff pressure will be dumped automatically. (8) Press ARM button to store it as the brachial pressure and the LCD will show it as shown in left figure. (9) Change the cuff from VC-12 to small one, DVC-1.9 or DPC-2.5 for toe pressures. (10) Press MODE button to select toe pressure mode. (TOE LED will illuminate.) (11) Press probe selection button to select probe #2.

Cuff

(12) Wrap the cuff around the base of the big toe and affix the PPG probe to the pad of the toe with Velcro strips.

PPG probe

(13) Take the toe pressure the same way for the brachial. (Steps #6 to #7 of this section) Press the LEG/TOE button to store it as the toe pressure and the TBI will be displayed as shown left.

16

Quick Start

Toe Brachial Pressure Index

(14) Go to the next toe pressure on the other side. Note: Press the ARM or LEG/TOE button more than 2 sec to clear the pressure memory for the next patient.

17

3. APPEARANCE AND MODE SETTINGS 3-1. OPERATING CONTROLS 3-1-1. Front Right View 1 2 3 4

5

9 6 7 8

1. Printer:

To print velocity wave forms, systolic pressures, ABI/TBIs and velocity/pressure documentations.

2. Speaker:

Outputs Doppler sounds.

3. Volume control:

To adjust sound volume.

4. Probe holder #2:

For probe placement when not in use. Probe holder 2 can be removed by unscrewing the 2 screws. Fix the 2 screws to the unit.

5. Probe holder #1:

For probe placement when not in use.

18

Appearance and Mode Settings

Operating Controls

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 menu for mode settings.

3-1-2. Operating Panel 10

11

12

13

14

17

10. MODE LEDs:

16

15

Indicate the mode selected. (Mode 1, Mode 2, ARM/LEG, Toe) Illuminate sequentially while charging battery.

11. MODE button:

To select the mode of either the arterial Mode 1, venous Mode 2, ARM/LEG pressure or Toe Pressure mode. See “§ 3-2-1. Basic Modes” for details. When optional PPG/PV probe is connected, Mode 1 and Mode 2 correspond to AC and DC modes respectively.

19

Appearance and Mode Settings

Operating Controls

To change the direction of waveform by pressing longer than 2 sec when on Dopper measurement mode. To get 4 step calibration signal on chart. See “§ 3-4-5. 4 Step Calibration” for details. 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 “§ 3-2-3. Menu mode” for details.

14. Probe selection button:

To select the probe intended to use from the connected probes. The LED corresponding to the probe number will illuminate. Menu mode To fix the mode or value. To change the mode or setting.

15. INF/DUMP (Freeze) button: To inflate the blood pressure cuff. Press it the second time to stop the inflation or to dump the cuff during the deflation when necessary. (ARM/LEG and TOE modes) In case LED on the button does not blink due to low flow or arrhythmia, press it longer than 2 sec for the inflation. Press it again to stop the inflation or to dump the cuff during the deflation. Measuring blood velocity To freeze / unfreeze the waveform. Menu mode To move the cursor right. To change the mode or setting.

20

Appearance and Mode Settings 16. LEG/TOE button:

Operating Controls

To store and display the measured pressure value as a leg or toe pressure. (Freeze mode) To display ABI or TBI . (Measurement mode) To erase all pressure values by pressing longer than 2 sec. (Measurement mode) 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 a arm (brachial) pressure. (Freeze mode) To display ABI or TBI. (Measurement mode) To erase all pressure values by pressing longer than 2 sec. (Measurement mode) Menu mode To go back to previous menu or to get out of menu mode.

21

Appearance and Mode Settings

Operating Controls

3-1-3. Back Right View and Probe

18 19

22

20 21

25

24

23

18. Roll shaft:

To set paper roll.

19. Communication port:

To connect computer. (USB)

20. Probe connector #2:

To connect probe #2.

21. AC adaptor connector:

To connect the designated AC adaptor.

22. Power switch:

To turn on/off the unit. ON

23. Probe:

OFF

Multi-probe selection of 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 “§ 3-2-4-e. PRB-KEY” for the details.

25. Probe cap:

To protect the probe transducer tip when probe is not in use.

22

Appearance and Mode Settings

Mode and Menu

3-2. MODE AND MENU Note : For the mode and menu for options, see “§ 5-2-5. Menu for PPG” and “§ 5-35. Menu for PV”. 3-2-1. Basic Modes Smartdop has following five Basic Modes: 1. Arterial Blood Velocity

Mode 1

2. Venous Blood Velocity

Mode 2

3. Arm and Leg Pressure

ARM/LEG

4. Toe Pressure

Toe

5. Menu

For other functions and settings

Pressing MODE button changes basic mode for mode #1 through 4 and each mode LED selected will illuminate. (Basic mode can be changed only when on measurement mode.) Press MENU button to go to menu mode and MENU LED on the button will illuminate.

3-2-2. Changing Modes with Operation Buttons a. Measurement/Freeze Mode Press freeze (INF/DUMP) or probe button to freeze or unfreeze the waveform when on MODE 1 and MODE 2. Measurement :

For measurement blood velocity

Freeze :

For observing waveforms and numerical data

23

Appearance and Mode Settings

Mode and Menu

Note : 1. On Freeze mode, following waveforms are temporarily stored in the memory Freeze. Mode 1 : Waveform of the 5 sec before freezing Mode 2 : Waveform of the 25 sec before freezing 2. Pressing probe button also freezes and unfreezes waveform. Probe button can be set for other function upon PRB-KEY on menu mode.

b. WAVE/DATA Mode Press LEG/TOE button to change WAVE/DATA mode when on Doppler MODE 1 and 2.

c. Flow direction Press MODE button longer than 2 sec in measurement mode to change the direction of waveform. Reverse mode is available only on Doppler - Mode 1 and Mode 2. Forward:

Flow toward probe is processed as positive component.

Reverse:

Flow away from probe is processed as positive component.

Forward mode

Reverse mode

24

Appearance and Mode Settings

Mode and Menu

3-2-3. Menu Mode Press MENU button to go to menu mode and MENU LED will be on. a. Menu table

Note : *1 : GUIDANCE is available when on measurement mode of ARM/LEG and TOE. *2 : CALibration is available when on Doppler measurement mode of MODE 1 and 2. Selections in bold face in the table above are default settings. *3 : MEMORY - STORE is available only on Freeze mode.

25

Appearance and Mode Settings

Mode and Menu

b. Menu Operation (1) Press MENU button to go to Menu mode. Smartdop will display the menu depending on Basic Mode.

(2) Select the menu by pressing Up (PRINT) or Down (LEG/TOE) buttons and selected mode will be highlighted. Press Right (INF/DUMP) button to change the setting. Note : On menu mode, some of the buttons on operation panel work as cursor buttons as shown left. PRINT : Up ARM : Left LEG/TOE : Down INF/DUMP : Right Probe selection : Enter (3) For MEMORY mode, press Enter (or Right) to display sub menu and Up and Down to select each sub menu.

(4) Press Enter (or Right) to show the memory number, and press Up and Down to change the number. (5) Press Left to go back to previous menu or press MENU to get out of menu mode.

26

Appearance and Mode Settings

Mode and Menu

3-2-4. Menu Mode Details To get to following menu items, see “§ 3-2-3-b. Menu Operation”. Do the mode setting once and subsequent Smartdop use will revert to this mode. a. MEMORY - STORE (1) Press Enter (or Right) on STORE sub menu and the first memory number available will be shown automatically on right side of the menu. If necessary, change the number in which you wish to store the waveform including numerical data by pressing Up and Down. Note: The memory number with "*" indicates a data has been already stored on it. (2) Press Enter to store the data into the memory and it will go back to display the waveform automatically. Note: If you try to store it on the memory with other data already stored, the confirmation "OVERWRITE?" will be displayed. Press Enter to overwrite, or press any one of cursor buttons to cancel. In case a pressure data is stored before ARM or LEG/TOE button is pressed, it will not include the site information. Press ARM/LEG or TOE button to add the site on the data later on while showing the stored waveform on LCD.

27

Appearance and Mode Settings

Mode and Menu

b. MEMORY - READ (1) Select the memory number from which you wish to read the data (waveform and numerical data) by pressing Up and Down. (2) Press Enter button to read the data from the memory.

Memory number

Note: By pressing freeze button, frozen data is automatically stored on memory name "FREEZE". If you wish to see the data again after reading other data, read "FREEZE" from memory.

c. MEMORY - CLEAR (1) Select the memory number in which data you wish to clear by pressing Up and Down. The memory number with "*" indicates a data has been stored on it. (2) Press Enter and then the confirmation screen with waveform stored in the memory will be displayed as shown in the picture right. Press Enter to clear the memory, or press Left to cancel. Note : If the waveform selected is not the one you wish to clear, press Up and Down to select other memory #.

28

Appearance and Mode Settings

Mode and Menu

(3) Choose ALL and press Enter to clear all the data in the memories except "FREEZE", frozen data.

d. LANGUAGE (1) Press Enter or Right to select the language desired in which menus and messages are written. Languages:

English, Deutsch, Italiano, Español, Français

e. PRB-KEY (Probe button function) (1) Press Enter or Right to change the probe button function. FREEZE: PRINT:

Freezes/unfreezes waveform. Activates/deactivates printer.

FRZ&PRINT

Freeze and Print

Note : When on ARM/LEG and TOE modes, probe button works the same way as INF/DUMP button no matter what is selected on the PRB-KEY mode.

29

Appearance and Mode Settings

Mode and Menu

f. GUIDANCE This setting enables or disables the function of displaying guidance on the LCD while on ARM/LEG and Toe pressure modes. (1) Press Enter or Right to change the guidance mode. ON: OFF:

Displays guidance Not display guidance

Note : GUIDANCE mode can be changed only when on measurement mode.

f. CALibration (Doppler Mode 1 & Mode 2 - Measurement only) (1) Press Enter or Right to change the mode. ON:

Displays 4 step (3, 2, 1, 0, -1 kHz) calibration waveform on the LCD.

OFF: Measurement mode

30

Appearance and Mode Settings

LCD Display

3-3. LCD DISPLAY 3-3-1. Blood Velocity Modes Waveforms (1) The base line is automatically located at best position. Smartdop has 4 base lines, the bottom, 1/4 from the bottom, the center, and 3/4 from the bottom. (2) The waveform amplitude is automatically adjusted for optimal observation. (3) The velocity amplitude scale per division is shown at top left of LCD.

Division

Amplitude scale

Mode 1

Mode 2

(4) When on freeze mode, the first half of waveform is shown on LCD. Press MODE to see the second half of waveform.

31

Appearance and Mode Settings

LCD Display

(5) Memory number is shown at top right of LCD for waveform read on MOMORY mode. e.g. "#01"

Memory number

Numerical data Press LEG/TOE button to change from waveform to numerical data on LCD as follows:

See “ 3-4-4. Numerical velocity prints” for the meaning of abbreviations of the parameters. 3-3-2. Pressure Modes Display samples in pressure measurement process

During blood pressure measurement

32

End of the measurement

Appearance and Mode Settings

LCD Display

After pressing LEG button

After pressing ARM button

(1) After freezing, press MODE to see the pressure documentation without numerical pressure on LCD. Press it the second time to show the numerical data again. (2) Pressing ARM or LEG/TOE button longer than 2 sec to clear the pressure data and the message shown right will appear. (3) Press ARM or LEG/TOE button to recalculate ABI/TBI for the 2 stored pressure data read from the memory.

Error messages When error occurs while measuring blood pressure, the following error messages will be displayed on the LCD: E1: E2:

(Reserved) Waveform error.

E3:

Pressure exceeded 300 mmHg.

E4:

Systolic pressure not found.

E5:

Time over.

E6:

Cuff pressure didn't go up.

33

Appearance and Mode Settings

LCD Display

Press any button other than probe selection button to delete the error message and proceed to next step.

3-3-3. Battery Indicators Battery level indicator

Battery level indicator

Battery level indicator shows top right of the menu screen. See “§ 2-3. Checking Battery Level” for details.

Low battery indicator When the battery is low, the low battery indicator will be shown on bottom right of LCD. Recharge the battery. See "§ 2-2. Charging / Discharging Battery" Low battery indicator

34

Appearance and Mode Settings

Printing Waveforms and Data

3-4. PRINTING WAVEFORMS and DATA 3-4-1. How to Print (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 : Mode 2 :

Waveform of the 5 sec before pressing PRINT button Waveform of the 25 sec before pressing PRINT button

Freeze mode Mode 1 :

Waveform of the 5 sec before freezing

Mode 2 :

Waveform of the 25 sec before freezing

ARM/LEG and Toe Pressure mode Systolic pressures, ABI/TBI and heart rate (Depend on stored pressure values) By pressing PRINT button longer than 2 sec, Velocity/Pressure documentation will be printed out after numerical data. (3) If necessary, press PRINT button the second time to deactivate printer while the printing is in progress.

35

Appearance and Mode Settings

Printing Waveforms and Data

3-4-2. Print Samples (1) Mode 1 (Artery)

*Time scale 0.2 sec/div. (approx. 25 mm/s) *Combined forward and reverse 0.2 sec

5 sec max.

(2) Mode 2 (Vein):

*Time scale 1 sec/div. (approx. 5 mm/s) *Separation of arterial from venous flow velocity 1 sec

25 sec max.

(3) ARM/LEG and TOE pressure modes (Pressing PRINT button less than 1 sec.) Arm only

36

Appearance and Mode Settings

Printing Waveforms and Data

Leg only

Toe only

Arm and Leg

Arm and Toe

Arm, Leg and Toe (Arm should be saved at the end.)

(4) ARM/LEG and Toe pressure modes (Pressing PRINT button longer than 2 sec.)

Pressure

Velocity

37

Sound reappearance

Appearance and Mode Settings

Printing Waveforms and Data

3-4-3. Time Scale and Baseline (1) Time scale a. Mode 1 (Artery): b. Mode 2 (Vein):

0.2 sec/div. (approx. 25 mm/s) 1 sec/div. (approx. 5 mm/s)

(2) Baseline The Smartdop adjusts the baseline automatically depending on how big the reverse component is. It has 4 baselines, the bottom, 1/4 from the bottom, the center, and 3/4 from the bottom.

3-4-4. Numerical Velocity Prints (1) Mode 1 (Artery) Parameters

Abbrs.

Systolic velocity

[cm/s]

S

Mean velocity

[cm/s]

MN

Heart rate

[bpm]

HR

(2) Mode 2 (Vein) Parameters

Abbrs.

Systolic velocity

[cm/s]

S

Mean velocity

[cm/s]

MN

Note: All computations are based on as follows: Mode 1 : Latest 3 beat average on measurement mode First 3 beat average on freeze mode Mode 2 : Latest 10 sec average on measurement mode First 10 sec average on freeze mode

38

Appearance and Mode Settings

Printing Waveforms and Data

If the heart rate can't be calculated because of an over +/-25% irregularity due to an Arhythmia or venous waveform, "HR:***" will be printed out as an error indicator.

3-4-5. 4 Step Calibration (Doppler Mode 1 & Mode 2 - Measurement mode only) To get the 4 Step Calibration signal to verify scaling, press the PRINT button to activate the printer and then depress MODE button while printer's running. The calibration signal will be printed out at the end of the waveform.

4 Step Calibration

39

Appearance and Mode Settings

External Outputs

3-5. EXTERNAL OUTPUTS 3-5-1. Headset Connect the headset when necessary. The headset cuts off the speaker. See “§ 3-1. Operating Controls”. 3-5-2. Communication Port 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 as well as a report of standardized testing modules. (1) Install the communication software Smart-V-Link, option, on your 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 detals.

40

Appearance and Mode Settings

Symbol List

3-6. SYMBOL LIST

41

4. MAINTENANCE 4-1. PERFORMANCE CHECK PROCEDURES BY USER Please perform the maintenance in case the unit is not in use for a while. Preparation (1) Check if appearance of main unit, probe and accessories is not damaged. (2) Check if wall voltage is good for rating input voltage of AC adaptor. (3) Turn the unit off. (4) Connect AC adaptor to the unit. (5) Connect the probe, suitable for intended clinical application, to the unit. Checking (1) Connect AC adaptor to the wall. (2) Turn the unit on. (3) Check if LCD works properly. (4) Set printing paper to the unit and check if it prints waveform properly. (5) Rub the probe tip and check 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.

4-2. 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.

42

Maintenance

Cleaning / Warranty

If using disinfectant, consult in advance with the manufacturer. 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. Inflatable cuffs The cuffs are intended for use only on intact skin. To clean, wipe away any dirt or stain using alcohol.

4-3. WARRANTY This equipment is guaranteed for the period of one year after the date of purchase when used under normal conditions. In the event of a problem during the warranty period, please contact your dealer. In case the warranty period is over, please consult the dealer for a charged service.

43

5. OPTIONS 5-1. OPTIONAL ACCESSORIES Doppler probes:

4, 5, 8 and 10 MHz (with curled or straight cable)

PPG probe :

Model PG-21

PV probe :

Model PV-20

PPG/PV probe :

Model PGV-20 (switchable single channel)

Cuffs :

DVC-1.9, DPC-2.5, VC-10, VC-12

Sphyg 3-way stopcock Smart-V-Link software with communication cable

5-2. PHOTOPLETHYSMOGRAPH With the PG-21 and PGV-20 (PPG mode), Smartdop senses the reflection of light from the hemoglobin of the red blood cells in surface vessels by utilizing infrared light. Basically, “How to use photoplethysmograph” is described in this manual. For other matters such as Cautions, Technical information and Interpretations of test result, refer to the Operating Manual comes with your PPG probe assembly.

44

Options

Photoplethysmograph

5-2-1. PPG (Photoplethysmography) Probe Assemblies Single-channel photoplethysmography (PPG) probe To the main unit Probe button

PPG probe head

Model PG-21 Switchable dual-modality (PPG/PV) single-channel probe To the main unit PPG/PV mode switch

PPG probe head

Model PGV-20

5-2-2. Clinical Applications AC Coupling:

Arterial pulse waveform studies, Toe pressure

DC Coupling:

Venous reflux study

5-2-3. 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 sensor site. When used with a suitable cuff and manometer, the method permits the measurement of systolic blood pressure in the fingers and toes.

45

Options

Photoplethysmograph

Preparation Round polarity mark

Probe connector #1

(1) Connect the PPG probe assembly to the probe connector #1 or 2 of the main unit, and turn the unit on. Note: With the PGV-20 probe, set the PPG/PV mode switch to the PPG mode beforehand. Make sure the probe selection LED illuminating corresponds to the connector you connected probe with. If not, press probe selection button to change it.

(2) Make sure Mode 1 LED (AC mode) illuminates. If not, press MODE button to select Mode 1 for AC mode.

(3) Check that the face of the PPG sensor is free of stains. Clean it if necessary. (4) Make certain that room temperature is comfortable and, especially, that the skin surface where the probe is to be mounted is warm. Cold constricts superficial blood vessels and thus jeopardizes the accuracy of PPG measurements.

46

Options

Photoplethysmograph

Examination Procedure (1) Apply the sensor with the clear side against the skin surface, and fix it in place using Velcro strips or double-sided clear tape. (2) The gain is automatically adjusted and the PPG waveform is shown on the LCD. Note : Pressing LEG/TOE button makes change the PPG sounds to beep sounds synchronized to heartbeats. (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 PRB-KEY is on Freeze mode. (4) If you wish to save the data on the memory, see “§ 3-2-4-a. MEMORY STORE”.

47

Options

Photoplethysmograph

5-2-4. PPG - Venous Reflux Study Purpose The venous reflux study is performed to assess valvular competence by measuring the amount of time required for venous refilling after calf veins have been emptied through exercise. Preparation Round polarity mark

Probe connector #1

(1) Connect the PPG probe assembly to the probe connector #1 or 2 of the main unit, and turn it on. Note: With the PGV-20 probe, set the PPG/PV mode switch to the PPG mode beforehand. Make sure the probe selection LED illuminating corresponds to the connector you connected probe with. If not, press probe selection button to change it.

(2) Make sure Mode 2 LED (DC mode) illuminates. If not, press MODE button to select Mode 2 for DC mode.

(3) To change the counting number for patient dorsiflexes, go to the menu and select COUNT and then press Enter (or Right) until the number becomes the one desired. Press MENU button to get out of the

48

Options

Photoplethysmograph Menu mode. (4) Check that the face of the PPG sensor is free of stains. Clean it if necessary. (5) Make certain that room temperature is comfortable and that the skin 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 clear tape. (3) Press PRINT or probe button to begin the measurement process. (4) Ask the patient to flex the foot specified number of times on COUNT following the foot animation on LCD. The exercise should be forceful, especially when lifting the foot upward.

49

Options

Photoplethysmograph (5) After flexing, instruct the patient to relax the foot and avoid all movement. (6) The test is complete when the waveform on the LCD returns to the baseline amplitude. Smartdop will automatically freeze the reflux study waveform and start to print it. Note : When PRB-KEY setting is on Freeze mode, Smartdop does not start printing automatically. Press PRINT button to print the waveform, if necessary. (7) If you wish to save the data on the memory, see “§ 3-2-4-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.

50

Options

Photoplethysmograph

5-2-5. Menu for PPG

Note : *1 : COUNT is used for DC mode when in Measurement mode. *2 : MEMORY - STORE is available only on Freeze mode. 5-2-6. 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: Mode 2:

AC coupling mode for arterial pulse waveform studies DC coupling mode for venous reflux study

COUNT (Only available in DC - Measurement mode) To get to COUNT setting, see “§ 3-2-3-b. Menu Operation”. Set the number of times for patient dorsiflexes. (1) Press Right or Enter until the number right side of the COUNT becomes the number of times for patient dorsiflexes.

51

Options

Pneumoplethysmograph

5-3. PNEUMOPLETHYSMOGRAPH With the PV-20 and PGV-20 (PV mode), Smartdop senses volume changes in a limb or digit by measuring the pressure changes in a recording cuff. Basically, “How to use pneumoplethysmograph” is described in this manual. For other matters such as Cautions, Technical informations and Interpretations of test result, refer to the Operating Manual comes with your PV probe assembly.

5-3-1. PV (Pneumoplethysmography) Probe Assemblies Single-channel pneumoplethysmography (PV) probe To the main unit

To the cuff

Model PV-20

Switchable dual-modality (PPG/PV) single-channel probe To the main unit PPG/PV mode switch

To the cuff

Model PGV-20

52

Options

Pneumoplethysmograph

5-3-2. Clinical Applications AC Coupling:

Arterial pulse waveform studies

DC Coupling:

Measurement of maximum venous outflow

5-3-3. PV - Arterial Pulse Waveform Studies Purpose Pneumoplethysmography is useful in detecting arterial occlusive conditions in the lower limbs through analysis of waveform patterns. The method is sufficiently sensitive for digital studies. PV also offers an alternative to Doppler techniques for segmental blood pressure studies. Pneumoplethysmography is particularly useful for patients in whom vessel calcification prevents accurate Doppler signal processing and occlusion-cuff pressure measurements. Preparation Round polarity mark

Probe connector #1

(1) Connect the PV probe assembly to the probe connector #1 or 2 of the main unit, and turn it on. Note: With the PGV-20 probe, set the PPG/PV mode switch to the PV mode beforehand. Make sure the probe selection LED illuminating corresponds to the connector you connected probe with. If not, press probe selection button to change it.

(2) Make sure Mode 1 LED (AC mode) illuminates. If not, press MODE button to select Mode 1 for AC mode.

53

Options

Pneumoplethysmograph

Examination Procedure (1) Place the patient in supine position with the leg and hip rotated outward. Use pillows to support the leg and hip comfortably. (2) Wrap cuffs of appropriate width around the thigh at the groin, above the knee, below the knee, and at the ankle on both limbs. Avoid wrapping cuffs tightly. The fit should be snug but comfortable. (3) Connect a 3-way stopcock to the inlet of the PV interface box. Interconnect the stopcock, tubing, cuff, and sphygmomanometer as shown in the diagram below. Sphyg Cuff Extender tubing

To Main unit

3-way stopcock PV interface box

(4) Turn the stopcock so that air is routed from the sphygmomanometer to the cuff. (5) Inflate the cuff to 60 mmHg. Then, turn the stopcock so that it blocks the sphyg and routs cuff pressure to the PV interface box. (6) The gain is automatically adjusted and the PV waveform is shown on the LCD. (7) When the waveform gets stable and rhythmic, press INF/DUMP button to freeze the waveform. Press PRINT button to print the waveform of last 5 sec, if necessary.

54

Options

Pneumoplethysmograph

(8) If you wish to save the data on the memory, see “§ 3-2-4-a. MEMORY STORE”. (9) Deflate the cuff and repeat steps #3 through #8 of this section for each cuff on each limb.

5-3-4. PV - Measurement of Maximum Venous Outflow Purpose Because deep venous occlusion cannot be diagnosed reliably on the basis 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 suddenly vented. Measurement of maximum venous outflow is frequently employed as an adjunct to Doppler venous compression studies. Preparation Round polarity mark

(1) Connect the PV probe assembly to the probe connector #1 or 2 of the main unit, and turn it on. Note: With the PGV-20 probe, set the PPG/PV mode switch to the PV mode beforehand.

Probe connector #1

55

Options

Pneumoplethysmograph Make sure the probe selection LED illuminating corresponds to the connector you connected probe with. If not, press probe selection button to change it. (2) Make sure Mode 2 LED (DC mode) illuminates. If not, press MODE button to select Mode 2 for DC mode.

Examination Procedure (1) Place the patient in supine position with the leg and hip rotated outward. Use pillows to support the leg and hip. It is important that the patient is comfortable and relaxed. (2) Wrap a wide occluding cuff at mid-thigh and a sensing cuff at mid-calf. (3) Connect a 3-way stopcock to the inlet of PV interface box. Interconnect the stopcock, tubing, cuff and sphygmomanometer as shown below. Sphyg Cuff Extender tubing

To Main unit

3-way stopcock PV interface box

(4) Turn the stopcock so that air is routed from the sphygmomanometer to the sensing cuff at mid-calf.

56

Options

Pneumoplethysmograph

(5) Inflate the sensing cuff to 40 mmHg. Wait 10 seconds to allow time for settling and deflate the cuff to 15 mmHg. (6) Turn the stopcock so that it blocks sphyg and routes cuff pressure to the PV interface box. (7) Disconnect the sphyg from the stopcock and attach it to the occluding cuff at the thigh. (8) Press PRINT button to begin the measurement process. (9) Inflate the occluding cuff at the thigh to at least 60 mmHg. Pressures in sensing cuff are plotted on the screen. The graph will indicate a gradual increase in waveform amplitude signifying that venous outflow is blocked by the occluding cuff. (10) After 90 seconds, disconnect the sphyg from the occluding cuff. The pressures on the screen will drop back to the baseline. (11) Smartdop will automatically stop the measurement process, and then freeze the waveform. Press PRINT button to print the waveform, if necessary. (12) If you wish to save the data on the memory, see “§ 3-2-4-a. MEMORY STORE”.

57

Options

Pneumoplethysmograph

(13) Press the INF/DUMP button to get out of the freeze mode.

5-3-5. Menu for PV

Note : *1 : MEMORY - STORE is available only on Freeze mode.

5-3-6. 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. AC: DC:

AC coupling mode for arterial pulse waveform studies DC coupling mode for measurement of maximum venous outflow

58

6. TECHNICAL INFORMATION 6-1. PRINCIPLES Model Smartdop 30EX is designed to obtain various blood flow velocity through the ultrasound which is transmitted from probe to patient body and is reflected by the blood (hemocyte, etc.). The unit amplifies the high frequency oscillation output and then supplies it to the transmitter transducer. It is converted to ultrasound by the transducer and the ultrasound is transmitted to external objects. The ultrasound moves straight through biophysical object, and is reflected by the moving object (blood flow, fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer 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 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 pressures mode, 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 signals should be stable. As the cuff pressure goes up by activating the inflation pump, the blood vessel is being pressed and the peak amplitudes become lower. The CPU finds the point where the peak amplitudes are below the threshold and waits until the cuff pressure is inflated an estimated 20 mmHg above the point. Then the CPU deactivates the inflation pump and lets the cuff pressure

59

Technical Information

Principles

go down at a moderate rate until the first blood flow signal that exceeds the threshold is detected. The cuff pressure at the first signal is the systolic pressure. After confirming a return of the rhythmical blood flow signals, the CPU opens the air valve to dump the cuff pressure and displays the systolic blood pressure on the LCD.

60

Technical Information

Block Diagram

6-2. BLOCK DIAGRAM

61

Technical Information

Specifications

6-3. SPECIFICATIONS Probes: (multi freq.)

Model

Freq.

BT4M05S8C BT5M05S8C BT8M05S8C BT10M5S8C

4 MHz 5 MHz 8 MHz 10 MHz

Probe power (Ispta) 300 mW/cm2 or less 300 mW/cm2 or less 300 mW/cm2 or less 300 mW/cm2 or less

Power:

Ni-MH rechargeable battery pack or AC adaptor, FRIWO model #: FW 3299/15.0974 Input: 230 V AC, 50 Hz Output: 12 V DC, 580 mA Fuse: 250 V, 80 mA Or 120 V AC, 12 V DC, 580 mA for US and Canada

Consumption:

DC 12 V, 500 mA

Recharge:

Approx. 4 hours by the AC adaptor

Full charge life:

7 hours or more with printing

Battery life:

Approx. 2 years, 300 full charges

Automatic shut-off

No signal: 5 min. Freeze: 10 min.

Frequency range:

200 Hz to 5 kHz

Mode settings:

Operation, Display, Direction, Memory, Others

Others: 15 min.

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 (pressure profile, ABI, TBI) Battery level and low battery indicators

Printer: Paper: Resolution: Print speed: Accuracy: Velocity: Heart rate: Pressure:

58 mm (W) x 25 m/roll (L), Thermal 256 dots/line Approx. 2.5 mm/sec ±10% or less comparing with internal phantom testing. ±5% ±5 mmHg

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Technical Information

Specifications

Speaker output:

250 mW or more

Inflation rate :

10 - 20 mmHg/sec

Deflation rate :

2 - 4 mmHg/sec

External outputs:

Headset, USB port

Electrical safety:

Conform to IEC60601-1 Internally powered equipment Type BF applied part.

Operating environment: 10 to 40 degrees Centigrade 85% humidity or less with no condensation Storage and transport environment: 0 to 50 degrees Centigrade 85% humidity or less with no condensation Dimensions: Main unit: Probe: Weight:

252 (W) x 192 (D) x 91 (H) mm (Probe holders not included) 20 (Diam.) x 105 (L) mm 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: 0401:

Feb/2003 Jan/2004

* Specifications subject to change

63

Technical Information

Safety Standards

6-4. 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) Leak current: Based upon IEC60601-1

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

SD30EX OM E-10 April, 2007 Printed in Japan 080-00114-1.0