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TABLE OF CONTENTSCautions

1. Introduction ...........................................................................................................................11-1. Features .........................................................................................................................11-2. Clinical applications........................................................................................................1

2. Appearance...........................................................................................................................22-1. View ...............................................................................................................................22-2. Main screen ...................................................................................................................4

3. Preparations .........................................................................................................................53-1. Power ON and OFF .......................................................................................................53-2. PDF & DICOM file options .............................................................................................63-3. Selecting probe ..............................................................................................................6

4. Measurement ........................................................................................................................75. Memory Screen ....................................................................................................................8

5-1. Store...............................................................................................................................95-2. Read ..............................................................................................................................95-3. Move ..............................................................................................................................95-4. Clear Menu ..................................................................................................................10

6. Settings ............................................................................................................................... 116-1. System Settings ........................................................................................................... 116-2. Basic Settings ..............................................................................................................12

6-2-1. Basics....................................................................................................................126-2-2. FFT........................................................................................................................136-2-3. Others ...................................................................................................................146-2-4. Numerical Data......................................................................................................15

7. Maintenance .......................................................................................................................167-1. Performance check by user .........................................................................................167-2. Cleaning .......................................................................................................................167-3. Probe sterilization.........................................................................................................167-4. Warranty.......................................................................................................................18

8. Supplemental information ...................................................................................................198-1. Numerical data .............................................................................................................198-2. Messages for sterilizable probes..................................................................................208-3. External outputs ...........................................................................................................208-4. Symbol List ..................................................................................................................218-5. Accessories..................................................................................................................218-6. Options.........................................................................................................................22

8-6-1. Optional accessories .............................................................................................228-6-2. Photoplethysmograph ...........................................................................................23

9. Technical information ..........................................................................................................249-1. Principles .....................................................................................................................249-2. Block diagram ..............................................................................................................259-3. Specifications ...............................................................................................................269-4. Safety standards ..........................................................................................................27

CAUTIONSPlease read the following important points carefully before you operate the unit.

1. Only skilled persons should operate the unit.

2. Use the unit for measuring blood flow.

3. Do not apply any modification to the unit.

4. Device placement:(1) Follow the requirements for storage and operating environments.(2) Do not put anything where disconnecting power supply of the unit could be obstructed. (3) Do not place it near water.(4) Do not place it where atmospheric pressure, temperature, humidity, ventilation,

sunlight, dust, salt, sulfur and so forth will affect the unit adversely.(5) Pay attention to the stability conditions to avoid too much inclination, vibration, shock,

and so on during transportation and installation of the unit.(6) Do not place it where chemicals are stored or gas may be generated. (7) Do not place it where the unit tends to fall.(8) Do not place the main unit in sterile area during surgery.

5. Before use:(1) Make sure that the AC adaptor is connected properly. (2) Use designated AC adaptor and power cable.(3) Make sure that all cables are connected correctly and safely.(4) Make sure that the unit operates safely and correctly by implementing performance

check mentioned in "§ 7-1. Performance check by user".(5) Using it with other equipment together may cause a misdiagnosis or danger to patient

due to a malfunction.(6) Double-check that all the cables do not obstruct any external connection to the patient.(7) Do not sterilize the main unit, non-sterilizable probes (model name starts with BT, BF

and BP) and amplifiers by gas, autoclave or so on to prevent any damage.(8) Sterilizable probes should be sterilized before use. (See § 7-3. Probe sterilization )

6. Operation:(1) Do not use the unit simultaneously with either electric cautery, cardioverter, other

ultrasonic device or mobile phone.

(2) Be cautious not to exceed too much time and volume required for the measurement. (3) Always make sure the unit and patient are not under abnormal conditions.(4) When any abnormality is found on the unit or the patient, take proper action such as

stopping use of the unit in a manner safe for the patient.(5) Do not let the patient touch the unit. (6) Use the designated accessories only.(7) Do not use the accessories for other devices.(8) Use the unit under the operating environments specified on the specifications. (9) Use the unit as specified in the operating manual.(10) Do not use the unit in a strong electromagnetic field or it may cause incorrect

measurement.(11) Do not connect any USB device to the USB port other than USB flash memory for

safety reasons.

7. After use:(1) Turn the unit off the way specified and unplug the power cable to cut off the AC power

from the unit.(2) Do not pull the cable(s) too much while disconnecting or it may cause damage.(3) Clean the unit, accessories, cables and probes and place them in right place for the

next use.

8. Storage:(1) Follow the caution #(1) to (7) of “§ 4. Device placement” in the previous page.(2) Clean the unit, accessories, cables and probes and place them in right place for the

next use.(3) When using the unit next time, perform the maintenance to make sure it works

properly and safely.

9. Maintenance(1) Do the periodical maintenance by following the procedures mentioned in "§ 7-1.

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.(3) Optional sterilizable probes (reusable & single use) can be sterilized in the manner

described in “§7-3. Probe sterilization”. However, only one time sterilization is doable for single use probes, and do not reuse them.Except autoclavable ACP probe, do not sterilize any probe by steam autoclave.

11. Ultrasonic gel(1) Do not apply ultrasonic gel to the probe body other than the tip of probe. (2) Using other materials such as baby oil and cream may damage the probe. (3) The ultrasonic gel enclosed is non-sterile and do not use it for surgeries.(4) Incidence of allergy: Discontinue the use of gel if any allergic reaction occurs.

12. 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.

13. Do not disassemble the unit.

14. Destruction(1) In case of destruction of the unit, follow the instructions for disposal of the destruction

appointed by each country or local government.

15. Any connected computer is not allowed to be in the patient area according to IEC60601-1.

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1. Introduction

Thank you very much for choosing the DVM-4500.

The Hadeco DVM-4500 is a uniquely designed bi-directional blood velocity & volume flow meter with large color touchscreen. Please read this manual carefully for complete product satisfaction.This medical device can be used by doctor for the purposes mentioned in the section"Clinical applications" for patients in hospitals and clinics.

1-1. Features � Bi-directional Doppler with 10-inch large color touchscreen� Simple design & operation with great Doppler sounds� Multi-probe selection of 4, 5, 8, 10 & 20 MHz� Exporting to PDF & DICOM® files for USB flash memory� Internal 30 waveform memory� All standard numerical parameters� PPG probe option for toe pressures

1-2. Clinical applications � Detection of arterial and venous blood flow velocity� Non-invasive vascular Doppler testing� Venous compression studies� Diagnostic ratio determinations - Peak, Mean & End diastolic� Intra-operative evaluations� Post-processing waveform analysis

2

2. Appearance 2-1. V iew

2 - 1 - 1. Fr ont view

1. Touchscreen

2. Probe connectors

3. Probe holders

1 Touchscreen To display and control waveform and numerical data.2 Probe

connectorsTo connect probe.

3 Probe holders For probe placement when not in use.

2 - 1 - 2. S i de view

4. Speakers

4 Speakers To output Doppler sounds (left and right sides)

3

2 - 1 - 3. R e ar vi e w

5. Power switch

7. Headset connector

8. USB port

9. Serial port

6. AC adaptor connector

5Power switchON: OFF:

To turn the unit ON and OFF.

6 AC adaptor connector To connect AC adaptor.

7 Headset connector To connect headset (Option).

8 USB port To connect USB memory.

9Serial port To connect computer with special USB

cable.

Z

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2-2. Main screen

1 3

4

10 5

6

7

8

9 9

1 button To open Memory Screen(See “5. Memory screen” )

2button

To open Basic Settings window(See “6-2 Basic Settings”)

3button

To open System Settings screen(See “6-1. System settings”)

4 Numerical data area To display numerical data5

Freeze buttonTo freeze the waveform

6 Mute button To mute the sound volumeNote: Mute is cleared if volume control button is

tapped.7 Volume control buttons To adjust the sound volume

8 Diameter type-in box To input estimated vessel diameterNote: It’s available when any Numerical Data for

Flow is being checked on Basic Settings. See “4. Measurement” for details.

9 Probe selection buttons To select the probe

10 Waveform area To display the waveform and mode icons.

5

3. P r e p arations3-1. Power ON and OFF (1) Connect power cable to the AC adaptor(fig.

A)

(2) Connect AC adapter to the AC adapter connector on the back of the unit (fig. B).

(3) Plug the power cable into wall outlet (fig. C).

Caution: Use the designated AC adaptor, ASTEC Model #: DPS54-M.

(4) Connect the probe to the probe connector so that the round polarity mark will be placed under mark, as shown on the right. (12 o’clock).

(5) Press power switch to turn the unit on and main screen will be shown in about 20 seconds.

Power ON: Power OFF:

AC adaptor

B

A

Power cable

C

Wall outlet

Round polarity mark

6

3-2. PDF & DICOM file options Tap System to open System Settings and check each checkbox for Export to PDF and DICOM toexport the file(s) for each waveform file whilemoving all data files to external memory. See “ 6-1. System Settings” for details.

3-3. Selecting probe Tap one of probe selection buttons for the probe you wish to use and selected button will turn in blue.

Probe selection button indicates the status as follows:Button status Description

Blue letters Probe selected

Gray letters Probe not selected

“None” Probe not connected

See ” 8-2. Messages for sterilizable probes” when sterilizable NP probe is connected.

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4. Measurement (1) Adjusting sound volume:

Tap volume control buttons and to adjust sound volume.

How to display volume flow data on main screen:(1) Check checkbox(es) for Flow MAX or/and MEAN on Numerical Data tab. See

“6-2-4.Numerical Data”.(2) Go back to main screen and tap diameter type-in box for typing estimated vessel

diameter value.

Note: Diameter type-in box is grayed out while all of the flow checkboxes are unchecked.

(2) Put ultrasonic gel on tip of probe or patient skin.

(3) Put the probe on the measurement area andmove it slowly to locate the point where themaximum Doppler sounds are heard. An ideal probe angle to the vessel is approximately 45 to60 degrees. When the waveform becomes rhythmical and stable, wait more than 5 sec without moving the probe.

(4) Press freeze button or probe button, if available, to freeze waveform data.

Probe button

(5) Tap Memory to store the waveform data, see “5.Memory Screen” for details.

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5. Memory Screen Memory Screen can be shown by tapping Memory on main screen for the memory operation of Store, Read, Move, Clear and so on for up to 30 waveform data.

1

2

39

456

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1 Selected memory Memory selected on System Settings is shown, eitherInternal or External Memory.

2 Thumbnail of frozenwaveform

Thumbnail for the waveform frozen on main screen isshown, not stored yet.

3 Data Information Data information for selected thumbnail is shown includingthe date and time for further identification.

4 Store button To store the frozen waveform (See “5-1.Store” )5 Read button To read stored waveform (See “5-2.Read” )6 Move button To move all of stored waveform(s) to external memory

(See “5-3. Move” )7 Clear Menu button To show Clear Menu for clearing data. (See “5-4.Clear

Menu)8 Return button To return to main screen9 Thumbnails of

stored waveformsThumbnails for up to 30 stored waveforms are shown.

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5-1. Store It stores frozen waveform on either internal or external memory selected on System Settings for up to 30 waveforms. After freezing waveform, follow the instructions bellow to store the data:

(1) After freezing the waveform, tap Memory on main screen to open Memory Screen and a thumbnail of frozen waveform will be shown on top right of the screen.

(2) Tap the one of thumbnail boxes where you wish to store the data and the selected box will be encircled by red line.

(3) Tap Store to implement it.

5 - 2. R e a d (1) Tap the thumbnail where you wish to read the

data and it will be encircled by red line.

(2) Tap Read and the waveform will be shown on main screen.

5-3. Move (1) Tap Move and follow the message to move all the

stored waveform data to the external memory connected to the USB port and moved data can be accessed through your computer only.

Note: Go to System Settings and check each checkbox for Export to PDF and DICOM to export the file(s) for each waveform file while moving all data files to external memory if desired.

Direct Move to USB flash memory:(1) To implement the Move function without going

through Memory Screen, connect USB memory

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to the port and the message will directly appearas shown in the right.

Folders in External Memory:In case External Memory is selected on System Settings, each waveform will be stored in the folder \Hadeco\DVM4500\0000. Every time the Move is implemented, all the stored waveforms will be moved in a new folder starting “0001” up to “9999” on externalmemory.

<Internal memory>Waveform data No. 1 - 30 (PDF file No. 1 - 30) Move

<External memory>[Folder name] [Contents]0 00 0 Waveform data No. 1 - 30

(DICOM file No. 1 - 30) Move (PDF file No. 1 - 30)(DICOM file No. 1 - 30)

0 00 1 Same as above0 00 2 Same as above

I I9 99 8 Same as above9 99 9 Same as above

5 - 4. Cl ear M e nu (1) Tap Clear Menu to show the menu.(2) Tap the thumbnail(s) or checkbox(es) to select

waveform(s) where you wish to clear the data. Tap Check All to check all checkboxes for clearing all data at once.

(3) Tap Clear and follow the message to proceed.

Data file names The file names of stored and/or moved waveforms in external memory are as follows:

ZCC data: “Memory #.ST2”FFT data: composed of 2 files, “Memory #.ST2” and “Memory #.SF1”PDF data: “Memory #.PDF”DICOM® data: “Memory #.DCM”

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6. Settings 6 - 1. S y stem S e t t ings

4

1

5

2

63

1. LanguageSelect your suitable language on pull-down menu.

2. Date & TimeSet the date and time when necessary.Note: The battery for internal clock lasts a few years depending on frequency of the unit

usage. Set the date and time when low battery message appears. Contact the dealer for battery replacement.

3. LandmarkCheck it to indicate the starting mark of each waveform as shown in the right.

4. ReturnTap it to return to main screen.

5. OutputStore Data To: Select it for either Internal or External Memory.Export to PDF: Check it to export each waveform to PDF file.

Starting marks

Export to DICOM(R): Check it to export each waveform to DICOM® file.

6. AutoAuto Freeze: Check it to freeze waveform automatically when waveform becomes stable.Auto Store: Check it to store waveform automatically when freezing waveform.

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6-2. Basic Settings 6-2-1. Basics

Basics items Descriptions

ZCC or FFT Basic mode:ZCC mode for practical mean velocity waveforms

FFT mode for frequency analysis of PEAK, MEAN, & power spectrum waveforms.

Scale Waveform amplitude scale:Auto: Auto-scale control2.5 to 160: Manual scale setting(When on manual scale setting, up and down buttons show up on left edge of main screen and scale can be changed easily by tapping the buttons.)

Baseline Baseline position:Auto: Auto-baseline controlUpper/ Center/ Lower/ Bottom: Manual baseline setting(When on manual baseline setting, baseline can be moved easily by tapping upper and lower area of baseline shown.)

Wave Mode Waveform mode:Compound: Combined forward and reverse components.

Separate: Separation of forward from reverse component.

Direction Flow direction mode:Forward: Flow toward probe processed for positive components

Reverse: Flow away from probe processed for positive components

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Time Scale Time scale:Normal: For arteries (1 sec/div.)

Slow: For veins (5 sec/div.)

6 - 2 - 2 . F F T FFT tab is available only while FFT mode is selected on Basics tab.

FFT items Descriptions

Display Type FFT display mode: Spectrum mode Envelope modeSpec / Env (Spectrum & Envelope) mode

Spectrum mode Envelopes mode

Wave Mode FFT waveform mode:MAX / MEAN: MAX & MEAN envelopesMAX: MAX envelopeMEAN: MEAN envelope

Each envelope is colored as follows:

Flow components

Forward Reverse

MAX Red Blue

MEAN Pink Light blue

Analog Gain Analog gain:Auto: Auto-gain control1 to 8: Manual gain setting

Threshold Threshold:1 to 20

Any signals lower than threshold will be filtered out as noise signals. Recommended settings: 10 +/- 3 for carotid 8 +/- 3 for lower extremities

6 - 2 - 3 . Oth e rs

Others items Descriptions

Unit Unit for blood velocity:

cm/s kHz

Filter Low-pass filter

Arterial filter (200Hz) Venous filter (80Hz)

Smoothing Smoothing frequency

Normal: For normal signals (10Hz) Low-pass: For noisy signals (5Hz)

Note: It’s available only while ZCC mode is selected on Basics tab.

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15

6 - 2 - 4 . N u m e rical Data Check all checkboxes for the numerical data you wish to display on main screen. Up to 4 data can be shown for each of the categories, Velocity, Flow, & Parameters.

For ZCC mode For FFT mode

Bayonet flexible

Bayonet extra-thin

10 MHz:20 MHz:20 MHz:

NP10M2N8AF NP20M12S8AF NP20M1S8A

Vascular:Lapaloscopic:

8 MHz:8 MHz:

VRP-08*¹LRP-08*¹ *1: Amplifier BDP08MS8 required.

Flat: 8 MHz: FDP-08*¹ Do not sterilize amplifier.Autoclavable: 8 MHz: ACP-08*¹Cardiovascular: 10 MHz TK10M3S8AF

10 MHz TK10M4S8AF10 MHz TK10M5S8AF

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7. Maintenance 7 - 1. P e r f o r ma n ce check by userPerform the following performance checks at least once a year:(1) Make sure if there is no damage and/or crack on the main unit and probe.(2) Shake the main unit and make sure if there are no sounds inside from internal

components coming out.(3) After turning the unit on, rub the probe tip and make sure if the unit makes Doppler

sounds and displays the waveforms properly.

7 - 2. Cl eaning PROBERemove the Doppler gel from tip of probe 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.

MAIN UNITTo 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. Check the unit by maintenance procedures mentioned in " § 7-1.Performance check by user" before using the unit.

7-3. Probe sterilizationSterilizable probes:Neurovascular:

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SterilizationOnly sterilizable probes can be sterilized. Do not sterilize other type of probes including amplifiers as well as main unit.

WarningsSterilizable probes are not sterilized before shipment. They must be sterilized before use as follows:

Sterilization limits1. All sterilizable probes except ACP probe: Up to 50 times2. ACP probe: Up to 5 times by steam autoclave

Note. Do not exceed sterilization limits or it may cause damage to probes.

Caution1. Except ACP probe, do not sterilize probes by steam autoclave nor put them in

washer disinfector or it will damage probes.2. ACP probe should be sterilized by steam autoclave as described in section

"Sterilization" below.

Instructions for sterilizationPoint of preparation: No particular requirements. Preparation for cleaning:

No particular requirements.Cleaning:

Automated Do not do automated cleaning of probes other than ACP probe. Manual Do not soak probes into medicinal solution. Wipe any

contamination from probes with damp cloth.Disinfection: Not applicableSterilization:

Sterilizable probes except ACP probeLow temperature plasma sterilization (Hydrogen peroxide low temperature plasma sterilization), under 60 degrees (C).Do not put liquid, powder & cellulose inside sterilization equipment or it may reduce effectiveness of sterilization because these substances absorb hydrogen peroxide. Eliminate water on surface of probe because it may reduce effectiveness of sterilization.Sterilization should be performed in accordance with instructionsof the sterilization equipment.

ACP probe

Steam autoclave;30 minutes under 115 degrees (C)

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Drying:

20 minutes under 121 degrees (C)10 minutes under 134 degrees (C)Do not expose probes to temperatures exceeding 134 degrees (C). Sterilization should be performed in accordance with instructions of the sterilization equipment.

Sterilizable probes except ACP probe:No particular requirements.

ACP probe: Dry it well after the sterilization. Maintenance: No particular requirements. Inspection and Function Testing:

No cracks nor contaminations in appearance.Connect the probe to main unit and make sure if you hearDoppler sounds properly when you rub probe tip.

Packaging: No particular requirements.Storage: No particular requirements. Manufacturer contact:

Hadeco, Inc.2-7-11 Arima, Miyamae-ku, Kawasaki, 216-0003, JapanTel : +81-44-877-4361 Fax : +81-44-855-7301

The instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and personal in the processing facility achieve the desired result. This requires validation and routine monitoring of process. Likewise any deviation by the processor from the instruction provided should be evaluated for effectiveness and potential adverse consequences.

7 - 4. W a rranty Guarantee period: * Frequency / - Diameter

Main unit Two(2) years

Probe

BT*M05S8C, BP*M05S8A, BF8M15S8A, VRP-08, LRP-08,

FDP-08, ACP-08, BDP08MS8, TK10M-S8AF

One(1) year

NP20M1S8A, NP10M2N8AF, NP20M12S8AF Three(3) monthsThe guarantee period is after the date of purchase when used under normal conditions. In the event of a malfunction during the warranty period, please contact your dealer.In case the warranty period is over, please consult the dealer for a charged service.

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8. Supplemen t al information 8-1. Numerical data 8 - 1 - 1 . Z C C N u me rical Da t a

Data Descriptions

Velocity

MAX Maximum velocity [cm/s] or [kHz]MEAN Mean velocity [cm/s] or [kHz]MIN Minimum velocity [cm/s] or [kHz]D End diastolic velocity [cm/s] or [kHz]

FlowMAX Maximum volume flow [ml/min]MEAN Mean volume flow [ml/min]

Parameters

SD Systolic Diastolic ratio: MAX / DPI Pulsatility Index: (Peak to Peak) / MEAN PI ≤ 99.99RP Resistance Parameter: (MAX - D) / MAX

RP=1 if waveform goes below baseline.HR Heart rate [BPM]

8 - 1 - 2 . F F T N u m e ric a l Da t a

Data Descriptions

Velocity

MAX S Maximum of MAX envelope [cm/s] or [kHz]MAX D End diastole of MAX envelope [cm/s] or [kHz]MN S Maximum of MEAN envelope [cm/s] or [kHz]MN V Mean of MEAN envelope [cm/s] or [kHz]MN D End diastole of MEAN envelope [cm/s] or [kHz]

FlowMAX Maximum of volume flow [ml/min]MEAN Mean of volume flow [ml/min]

Parameters

SB Spectral Broadening: (MAX S - MN S) / MAX S x 100 [%]SD Systolic Diastolic ratio: MN S / MN DPI Pulsatility Index: (Peak to Peak) / MN V PI ≤ 99.99RP Resistance Parameter: (MN S – MN D) / MN S

Note: RP=1 if waveform goes below baseline.HR Heart rate [BPM]

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8-2. Messages for sterilizable probes Message shown below will appear when the sterilizable NP probe is connected:

Tap OK to proceed the measurement and it will be counted internally.In case message is left for 1 minute without tapping OK, Doppler sounds will cease and new message shown below will appear:

Tap OK to proceed or turn the unit off to cancel the measurement.When the counted number on usage of the sterilized probe reaches certain number, a message shown below appears. It is recommended to replace the probe with new one.

8-3. External outputs

8 - 3 - 1 . Hea d set Connect the headset when necessary. It cuts off the speaker.

8 - 3 - 2 . US B p o rt Connect a USB flash memory as external memory to the main unit to save the waveforms. PDF and DICOM data file(s) can be exported to the external memory if desired.Note: Do not connect any USB device to the port other than USB flash memory for safety reasons.

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8-4. Symbol List

Symbol Description Symbol Description

Power OFF Power ON

AC adaptorConnector

Headset

USB Port Serial port

Type CFapplied part

Probe connection

polarity

Caution*

* Caution must be observed to avoid damage to the unit. Refer the operating manual carefully.

8 - 5 . Accessories

Probe ························· 2AC adaptor ················· 1Power cable ··············· 1Ultrasonic gel ············· 1Operating manual ······ 1

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8-6. Options

8-6-1. Opti o n al accesso r i es Doppler probes:

Standard type: 4 MHz: BT4M05S8C (A)5 MHz: BT5M05S8C (A)

Pencil type:

8 MHz:

8 MHz:

BT8M05S8C (A)

BP8M05S8A

Flat type: 8 MHz: BF8M15S8A

Sterilizable probes:Neurovascular:

Bayonet flexible 10 MHz: NP10M2N8AF (2 mm diam.)20 MHz: NP20M12S8AF (1.2 mm diam.)

Bayonet extra-thin 20 MHz: NP20M1S8A (0.8 mm diam.)Vascular: 8 MHz: VRP-08*¹Lapaloscopic: 8 MHz: LRP-08*¹Flat: 8 MHz: FDP-08*¹Autoclavable: 8 MHz: ACP-08*¹

*1: Amplifier BDP08MS8 required.Do not sterilize amplifier.

Cardiovascular: 10 MHz TK10M3S8AF (3 mm diam.)10 MHz TK10M4S8AF (4 mm diam.)10 MHz TK10M5S8AF (5 mm diam.)

Amplifier 8 MHz: BDP08MS8

PPG probe: PG-21

Others: Headset

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8 - 6 - 2 . P h ot o plet h y s m o g r a p h With the PG-21, the unit 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 section. For other matters such as Cautions, Technical information and Interpretations of test result, refer to the Operating Manual that comes with your PPG probe.

Clinical applications:AC Coupling: Arterial pulse waveform studies, Toe pressure

PPG (Photoplethysmography) Probe Assembly:Single-channel photoplethysmography (PPG) probe: Model PG 21

To the main

Probe

PPG probe

PPG-Arterial pulse waveform studies:

PurposeArterial 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.

Preparation(1) Connect PPG probe to the main unit, and turn it on.(2) Tap probe selection button for the PPG probe connected.

Examination Procedure(1) Apply the sensor with the clear side against the skin surface, and fix it in place using

Velcro strap or double-sided clear tape. High-pitched sounds following heart beats can be heard from the speaker.

(2) When the waveform becomes stable and rhythmic, tap freeze key to freeze waveform.If you wish to store the data on the memory, see “5 Memory Screen” for details.

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9. Technical information

9-1. PrinciplesThe unit 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 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 shifted signals are

amplified and are converted to audible sounds through a speaker or a headset.

Simultaneously, the Doppler shifted signals are applied to the CPU and converted to blood

flow velocity waveform signals which can be displayed.

Reinforced Isolation

Isolation Serial port

Probe 1

25

9-2. Block diagram

Memory

LCD

TouchscreenCPU

USB Connector

Signal converter

Speaker

Probe 2

Type CF applied part

Preamplifier Power amplifier

Headset

Power switch

Power supplyAC

AC adaptor

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9-3. Specifications

Probes:Frequency Acoustic power Ispta [mW/cm2]

4 MHz 390 or less5 MHz 390 or less8 MHz 390 or less

10 MHz 94 or less20 MHz 94 or less

Power: AC adaptor Model #: DPS54-M Input: AC100 - 240V Output: DC15V 4A

Consumption: DC15V, 1.2A

Measurement range: 80 / 200 Hz to 13 kHz

Measurement accuracy:±10% or less comparing with internal phantom testing.

Heart rate: 30 to 240 BPM ± 5%

Vessel diameter: 0.1 – 20 [mm]

Waveform memory: 30 waveforms

LCD touchscreen: TFT LCD, 10.4 inch 800 x 600 dots

Speaker output: 2.4 [W] (1.2W+1.2W)

External outputs: Headset, USB port & Serial port

Electrical safety: Conforms to IEC60601-1Type CF applied part.

Operating environment:10 to 40 degrees Centigrade85% humidity or less with no condensation

27

Storage and transport environment:0 to 50 degrees Centigrade85% humidity or less with no condensation

Dimensions: 300 (W) x 167 (D) x 244 (H) mm

Weight: 2.7 Kg (Including AC adaptor)

Manufacturing date:The first 2 digits and following 2 digits of the serial number represent the year and month of manufacturing, respectively.It consists of 7 to 8 digits and may start with “Serial number” or“SN”.

Examples:12080001: Aug/ 20121208001: Aug/ 2012

* Specifications subject to change

9-4. Safety standardsThe unit confirms to the following standards: Manufacturing standard: IEC60601-1

(1) Protection class against electric shock : Class II deviceProtection grade against electric shock : Type CF applied part

(2) Leak current:Based upon IEC60601-1Items Normal Single faultTouch current 100 uA or less 500 uA or lessPatient leak current 10 uA or less 50 uA or less

Guidance and manufacturer's declaration - electromagnetic emissions and immunity.

Guidance and manufacturer’s declaration – electromagnetic emissionsThe DVM-4500 is intended for use in the electromagnetic environment specified below. The customer or the user of the DVM-4500 should assume that it is used in such an environment.

Emissions test compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The DVM-4500 use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearbyelectronic equipment.

RF emissions

CISPR 11

Class A The DVM-4500 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 orrelocating the DVM-4500 or shielding the location.

Harmonic emissions

IEC61000-3-2

Class A

Voltage fluctuations/ flicker emissionsIEC61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunityThe DVM-4500 is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the DVM-4500 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

±6kV contact

±8kV air

±6kV contact

±8kV air

Floors should be wood, concrete or ceramic tile. If floors are converted with synthetic material, the relative humidity should be at least30 %.

Electrical fast transient/burst

IEC61000-4-4

±2kV for power supply lines

±1kV for input/output lines

±2kV for power supply lines

±1kV for input/output lines

Mains power should be that of a typical commercial or hospital environment.

Surge

IEC61000-4-5

±1kV differential mode

±2kV common mode

±1kV differential mode

±2kV common mode

Mains power should be that of a typical commercial or hospital environment.

Voltage dips, shortinterruptions andvoltage variations

<5% UT

（>95% dip in UT）for 0,5 cycles

<5% UT

（>95% dip in UT）for 0,5 cycles

Mains power should be that of a typical commercial or hospital environment.

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on power supply input lines

IEC61000-4-11

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

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

Power frequency (50/60Hz) magnetic field IEC61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospitalenvironment.

NOTE UT is the a.c. mains voltage prior to application of the test revel.

Guidance and manufacturer’s declaration – electromagnetic immunityThe DVM-4500 is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the DVM-4500 should assure that it is used in such an environment.Immunity test IEC60601 test level Compliance

levelElectromagnetic environment - guidance

Conducted RF IEC61000-4-6

Radiated RF IEC61000-4-3

3Vrms150kHz to 80MHz

3V/m80Mhz to 2.5GHz

3V

3V/m

Portable and mobile RF communications equipment should be used no closer to any part of the DVM-4500, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1,2√P

d = 1,2√P 80 to 800MHz

d = 2,3√P 800MHz to 2,5GHz

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where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strength from fixed RF transmitters, as determined by an electromagnetic site

survey, a should be less than the

compliance level in each frequency range. b

Interference may occur in the vicinity of the equipment marked with 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 affectedby 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, 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 DVM-4500 is used exceeds the applicable RF compliance level above, the DVM-4500 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the DVM-4500.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Manufactured by

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

DVM4500 OM E-10August, 2012

Printed in Japan080-00185-1.0