MINIDOP ES-100VX Operating Manual May 2018

Thank you very much for choosing the Minidop ES-100VX. The POCKET DOPPLER Minidop ES-100VX can be used with interchangeable probes having different frequencies of 2, 4, 5, 8, 10 and 20 MHz, to detect arterial and venous blood flows in the extremities. Please read this manual carefully.

Features ES-100VX is designed for the use to detect arterial & venous blood flows in the extremities, and has the following features. ・ POCKETABLE, HAND-HELD SIZE ・ GREAT SENSITIVITY ・ WIDE PROBE SELECTION (2, 4, 5, 8, 10 and 20 MHz) for user flexibility. ・

CONVENIENT PROBE ACTIVATION BUTTON turns ES-100VX ON and OFF.

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Cautions 1. General Non-conformability with expendables / components / other device Please use designated battery, ultrasonic gel, probe and headset. Do not use those components for other devices. Only skilled persons should operate the unit. 1-1. Probe (1) The standard probe is for transcutaneous use only. (2) Optional sterilizable probe (reusable & disposable) can be sterilized in the manner described in the page 14, Sterilization. However, only one time sterilization is possible for disposable probe, and do not reuse it. (3) Except optional ACP probe, do not sterilize probes by steam autoclave. (4) The probe transducer is a very thin and delicate. Please handle with great care and use the probe cap when not in use. (5) The probe cover also prevents against switching ON when storing the unit after use. 1-2. Ultrasound gel (1) Do not apply ultrasound gel to the probe body other than the tip of probe. (2) Always use an ultrasound gel. Using other materials such as baby oil and cream may damage the probe. (3) The ultrasound 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.

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1-3. Battery (1) When battery is low, the power indicator flashes. Replace the battery. (2) Use a 9 volt alkaline square type battery. A non-alkaline may cause a shortage of power. (3) When not using the unit for a long time, remove the battery.

2. Before using the unit (1) Make sure that the unit operates safely and correctly by implementing performance check mentioned in “Cautions 7. Periodical safety check by user”. (2) Do not place near water or other liquid. (3) Do not place where atmospheric pressure, ventilation, sunlight, dust, salt, sulfur and so forth will not affect the unit adversely. (4) Do not place it on or adjacent other electronic device. (5) Use only on conditions of temperature between 10 °C and 37 °C and humidity less than 85 %. (6) Pay attention to the stability conditions to avoid too much inclination, vibration, shock, and so on during transportation and installation of the unit. (7) Do not place it where chemicals are stored or gas may be generated. (8) Keep the unit and the patient from a computer more than 1.5 m apart. (9) When using the unit after a long time, do not forget to check whether the unit operates normally and safely. (10) Make sure that there are no damages on the unit and probe. (11) Clean the probe using damp cloth or a recommended probe cleaner before use. Using alcohol or thinner may damage the probe. (12) Sterilizable probes (optional) should be sterilized before use. (See Page 12, 3

Sterilization) (13) Do not sterilize the main unit, non-sterilizable probes and amplifier to prevent any damage. (14) Using it with other equipment together may cause a misdiagnosis or danger to patient due to a malfunction.

3. When operating the unit (1) Do not use the unit simultaneously with either electric cautery, cardioverter, other ultrasonic device or mobile phone. (2) 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. (3) Possibility of operation under unexpected environments (4) Please do not use the Doppler continuously for more than 1 hour to avoid a rash of the skin. (5) Do not use the unit in a strong electromagnetic field or it may cause incorrect measurement. (6) Be cautious not to exceed too much time and volume required for the measurement.

4. After using the unit (1) Turn the unit off, and disconnect all cables. (2) Clean the unit, components, cables and probes. (See Page 18, Cleaning)

5. When the unit gets out of order, contact the dealer for repair from who you purchased the unit. 6. Do not disassemble the equipment.

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7. Periodical safety checks by user Please perform the following safety 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) Turn the unit on and make sure if the pilot lamp goes on.

8. Destruction (1) In case of destruction of the unit, follow the instructions for disposition of the destruction appointed by each country or local government. (2) Do not place battery in fire or it may cause an explosion and injury.

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Clinical applications Use the unit for the following clinical applications only: ・ Blood flow detection

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Operating controls Front panel

1. Probe connector

: To connect probe.

2. Headset

: To connect headset.

3. Connector for

: Not allowed to use it. Only for service purpose.

4. Volume control

: To adjust sound volume.

5. Power indicator

: Indicates power ON/OFF and Low Battery Charge with flashing.

6. Speaker

: Outputs Doppler sounds.

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Rear panel

7. Probe holder

: For probe placement when not in use.

8. Strap holes

: To connect neck strap.

9. Battery cover

: For battery placement.

10. Probe

: Multi-probe selection of 2, 4, 5, 8, 10 and 20 MHz.

11. Probe button

: To turn the unit ON / OFF.

12. Probe cap

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

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How to turn the unit ON and OFF (1) Open the battery cover as pictured on the right.

To prevent any damage to the battery terminal, please insert the battery to battery box as shown right.

(2) Set an alkaline square type battery in the unit ensuring that the

positive

and negative

electrodes correspond to the + and - marks on the label in the battery box. (3) Connect the probe to the Minidop so that the arrow mark

will be placed under

mark,

and press the probe button to turn the unit ON. To start the measurement, turn the volume control to maximum. (4) Press the probe button again to turn the unit OFF. AUTOMATIC SHUT-OFF If the unit is left on with no signal input, the power is automatically shut off in about 3 minutes. REPLACING BATTERY Replace the battery with new one if the power indicator flashes. Use a 9 volt ALKALINE square type battery. A non-alkaline may cause a shortage of power. Note: Use the battery composed in the package as a standard component for performing operation check only. 9

External outputs HEADSET Connect the headset when necessary. The headset cuts off the speaker.

Operation (1) Connect the probe to the Minidop so that the arrow mark

will be placed under

mark, as

shown on the right.

(2) Put ultrasonic gel on the probe top or patient skin. Press the probe button to turn the unit on.

(3) Make sure the power indicator on the unit is on. Turn the volume control to maximum.

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(4) 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°.

(5) If you are using the 2 MHz probe, put the probe on the measurement area and move it slowly to locate the point where the maximum sounds are heard.

Skin surface

(6) Headset can be used to listen to Doppler sounds. It will cut off the speaker.

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Probe selection The frequency of diagnostic ultrasound is inversely proportional to depth of penetration. The Minidop has 5 interchangeable probes with different frequencies. Use those probes depending on your applications. BT2M20S8C (2 MHz):

Deep peripheral blood flow

BT4M05S8C (4 MHz):

Deep peripheral blood flow

BT5M05S8C (5 MHz):

Deep peripheral blood flow

BT8M05S8C (8 MHz):

Superficial blood flow

BT10M5S8C (10MHz):

Superficial blood flow

Clinical applications ・ Detection of Arterial and Venous Blood Flow Velocity for vascular disease. Probes to be used: BT2M20S8C (2 MHz) BT4M05S8C (4 MHz) BT5M05S8C (5 MHz) BT8M05S8C (8 MHz) BT10M5S8C (10MHz)

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Options Probe selection Standard Doppler probe: Standard: 2MHz:

BT2M20S8C

4MHz:

BT4M05S8C

5MHz:

BT5M05S8C

8MHz:

BT8M05S8C

10MHz: BT10M5S8C Pencil: 8MHz:

BP8M05S8A

10MHz: BP10M5S8A Flat: 2MHz:

BF2M20S8A

8MHz:

BF8M15S8A

Sterilizable probes: (Amplifier required) Small pencil: 8MHz:

VRP-08

10MHz: VRP-10 20MHz: VRP-20 Long: 8MHz:

LRP-08

10MHz: LRP-10 Flat: 8MHz:

FDP-08

8MHz:

ACP-08

Autoclavable:

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Bayonet*: 10MHz: NRP-10H 20MHz: NRP-20H Flexible*: 10MHz: NRP-10HF 20MHz: NRP-20H1NF Curved pencil*: 10MHz: CRP-10H 20MHz: CRP-20H 20MHz: CRP-20H1N Single use*: 10MHz: NDP-10H 20MHz: NDP-20H *: Except European Union Countries Amplifiers: 8MHz:

BDP08MS8

10MHz: BDP10MS8 20MHz: BDP20MS8 -- Sterilizable probes -Sterilization Only sterilizable probes can be sterilized. Do not sterilize other type of probes including amplifiers as well as main unit. Warnings Sterilizable probes are not sterilized before shipment. They must be sterilized before use as follows:

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Sterilization limits All sterilizable probes except ACP and FDP probe: Up to 50 times FDP probe: Up to 5 times ACP probe: Up to 5 times (steam autoclave) Note: Do not exceed sterilization limits or it may cause damage to probes. Caution Except ACP probe, do not sterilize probes by steam autoclave nor put them in washer disinfector or it will damage probes. ACP probe should be sterilized by steam autoclave as described in section "Sterilization" below. Instructions for sterilization Point 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 it into medicinal solution. Wipe any contamination from probes with damp cloth.

Disinfection:

Not applicable.

Sterilization: Sterilizable probes except ACP probe: Low temperature plasma sterilization (Hydrogen peroxide low temperature plasma sterilization), under 60 °C. Sterilization system is compatible with only the STERRAD® by Johnson & Johnson, K.K. sterilization system as follows: ・STERRAD®50 ・STERRAD®100S (only short cycle) ・STERRAD®200 (only short cycle) ・STERRAD®NX (only standard cycle) ・STERRAD®100NX (only standard cycle) 15

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 instructions of the sterilization equipment. ACP probe: Steam autoclave: 30 minutes at 121 °C 4 minutes at 134 °C Do not expose the instrument to temperatures exceeding 134°C. Sterilization should be performed in accordance with instructions of the sterilization equipment. Drying: Sterilizable probes except ACP probe: ACP probe:

No particular requirements.

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 hear Doppler 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, Japan Tel: +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. 16

Principles Model ES-100VX Minidop is designed to receive blood flow velocity information by ultrasound. A specific frequency is transmitted from the probe to the patient. Technically the transceiver amplifies a high frequency oscillation output for transmission to the transducer. The voltage is converted by a piezoelectric crystal (transducer) to ultrasound. The ultrasound beam is transmitted to blood cells flowing through arteries. The ultrasound beam is reflected by the red blood cells or by moving structures and received by the crystal in the transducer which converts the ultrasound into a voltage. A Doppler shift occurs between the emission and reception of the ultrasound beam. The voltage is amplified. The electronics amplifies the signal, filters out noise and improves the S/N ratio. The Doppler shift signals are amplified further and converted to audible sound via a speaker.

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Block diagram

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Specifications Probes:

Model: Freq.

Ispta* (in situ) [mW/cm²]

BT2M20S8C

2 MHz

80 or less

BT4M05S8C

4 MHz

390 or less

BT5M05S8C

5 MHz

390 or less

BT8M05S8C

8 MHz

390 or less

BT10M5S8C

10 MHz

390 or less

*Ispta: Spatial Peak - Temporal Average Intensity Battery:

DC 9 volts, Alkaline square type battery

Battery life:

Approx. 3 hours (Alkaline)

Automatic shut-off:

No signal: 3 min.

Probe button:

Power ON/OFF

Speaker output:

300 mW or more

External outputs: Headset:

Cuts off the speaker. (3.5 mm jack)

Dimensions:

Main unit:

78(W) x 141(L) x 27(H) mm

(not including probe holder) Probe:

20(Diam.) x 105(L) mm

Weight:

Approx. 240 grams (including battery & probe)

Electrical safety:

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

Operating environment: 10 to 37 °C 85% humidity or less with no condensation Storage and transport environment: 0 to 50 °C 85% humidity or less with no condensation Manufacturing date:

The first 2 digits and following 2 digits of the serial number represent the year and month of manufacturing, respectively. 19