OPERATING MANUAL MINIDOP ES-100VX POCKET DOPPLER

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OPERATING MANUAL MINIDOP ES-100VX POCKET DOPPLER CONTENTS * Features.......................... 1 * Cautions.......................... 2 * Clinical applications................. 4 * Operating controls.................. 5 * How to turn the unit ON and OFF....... 7 * External outputs.................... 8 * Operation......................... 8 * Probe selection and applications...... 10 * Principles........................ 11 * Block diagram..................... 12 * Specifications..................... 13 * Cleaning......................... 14 * Warranty......................... 14 Excellence in Human Service and Technology Hadeco, Inc. 100VX OM E-26 August 25, 2004 No. 080-00004-02

Thank you very much for choosing the MINIDOP ES- 100VX. The POCKET DOPPLER MINIDOP ES-100VX can be used with five interchangeable probes having different frequencies of 2, 4, 5, 8 and 10 MHz, to detect fetal heartbeats as well as arterial and venous blood flows in the extremities. Please read this manual carefully. FEATURES ES-100VX is designed for the use to detect fetal heartbeats and 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 and 10 MHz) For user flexibility. * CONVENIENT PROBE ACTIVATION BUTTON Turns ES-100VX ON and OFF. * AUTOMATIC POWER "OFF" 1

CAUTIONS 1. General Non-conformability with expendables/accessories/other device Please use designated battery, ultrasonic gel, probe and headset. Do not use those accessories for other devices. 1-1. PROBE (1) The standard probe is for transcutaneous use only. (2) The probe transducer is a very thin and delicate part. Please take care not to drop or hit the probe tip. After use, protect the transducer with probe cover. The probe cover also prevents against switching ON when storing the unit after use. 1-2. ULTRASOUND GEL (1) Always use an ultrasound gel. Using other materials such as baby oil and cream may not produce correct Doppler sound, but may damage the probe. (2) Incidence of allergy Please use other type of ultrasonic gel if there is an allergic reaction occurred after use of the probe with the gel. 1-3. BATTERY (1) When battery is low, the power indicator becomes dark. Also there will be no speaker sounds. 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

2. Before using the unit (1) Do not place near water or other liquid. (2) Do not place where atmospheric pressure, ventilation, sunlight, dust, salt, sulfur and so forth will not affect the unit adversely. (3) Use only on conditions of temperature between 10 and 40 degrees Centigrade and humidity less than 75 %. (4) Take care of the stability conditions such as inclination, vibration, and shock during transportation. (5) Do not place where chemicals are stored, or where gas may be generated. (6) Keep the unit and the patient from a computer more than 1.5 m apart. (7) When using the unit after a long time, do not forget to check whether the unit operates normally and safely. (8) Make sure that there are no damages on the unit and probe. 3. When operating the unit (1) When using the unit together with an electrosurgery unit or a defibrillator, disconnect the probe and the other cables while such a unit is being used. Neglecting this may cause a burn to the patient. (2) When any abnormality is found in the unit or in the patient, take proper action such as stopping operating the unit in a manner safe to the patient. (3) Possibility of operation under unexpected environments Please do not use the Doppler continuously for more than 1 hour to avoid a rash of the skin. 4. After using the unit (1) Turn power switch off, and disconnect all cables. (2) Clean the unit, accessories, cables and probes. (See Page 14, Cleaning) 3

5. When the unit gets out of order, call the dealer for repair from who you purchased the unit. 6. Do not remodel the equipment. 7. Periodical safety checks by user Please perform the following safety checks 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. CLINICAL APPLICATIONS Use the unit for the following clinical applications only: * Evaluation of fetal heart beat and sounds. * Peripheral vascular procedures. * Pedal pulse assessment. * Blood pressure segmental studies. * Venous compressions. * Penile & digit systolic pressures. 4

OPERATING CONTROLS Front panel 1. Probe connector : To connect probe. 2. Connector for : Not allowed to use it. Only for service services purposes. 3. Headset : To connect headset. 4. Volume control : To adjust sound volume. 5. CAL key for services : Not allowed to use it. Only for service purposes. 6. Power indicator : Indicates power On/OFF. 7. Speaker : Outputs Doppler sounds. 5

Rear panel 8. Probe holder : For probe placement when not in use. 9. Strap holes : To connect camera strap. 10. Battery cover : For battery placement. 11. Probe button : To turn the unit ON / OFF. 6

HOW TO TURN THE UNIT ON and OFF 1. Open the battery cover as pictured on the left. 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. 2. Connect the probe with the arrow up on the probe connector (12 o'clock), and depress the probe button to turn the unit ON. To start the measurement, turn the volume control to maximum. 3. Depress the probe button again to turn the unit OFF. 4. AUTOMATIC POWER OFF If the unit is left on, the power is automatically shut off in about 5 minutes. Note: The auto-off time depends on room temperature. 5. REPLACING BATTERY Replace the battery with new one if the power indicator becomes dark. Use a 9 volt ALKALINE square type battery. A non-alkaline may cause a shortage of power. 7

EXTERNAL OUTPUTS 1. HEADSET Connect the headset when necessary. The headset cuts off the speaker. OPERATION (1) Connect the probe to the MINIDOP with the round hollow mark up on the probe connector (12 o'clock). (2) Put ultrasonic gel on the probe top or patient skin. Depress 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. 8

(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 60 degrees. Skin surface (5) If you are using the 2 MHz probe to detect fetal heart beats, put the probe on the measurement area and move it slowly to locate the point where the maximum heart beat Doppler sounds are heard. Caution: Verify the fetal heart rate. (Maternal heart rates match the maternal pulse rates.) (6) Headset can be used to listen to Doppler sounds. It will cut off the speaker. 9

PROBES and APPLICATIONS 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): BT4M05S8C (4 MHz): BT5M05S8C (5 MHz): BT8M05S8C (8 MHz): BT10M5S8C (10MHz): Fetal heart beat and sounds Deep peripheral blood flow Deep peripheral blood flow Superficial blood flow Superficial blood flow * CLINICAL APPLICATIONS 1. Detection of Fetal Heart Sounds Probes to be used BT2M20S8C (2 MHz) Evaluation of fetal heart beat and sounds throughout pregnancy except where fetal heart is not developed sufficiently during the first trimester. 2. Detection of Arterial and Venous Blood Flow Probes to be used BT4M05S8C (4 MHz) BT5M05S8C (5 MHz) BT8M05S8C (8 MHz) BT10M5S8C (10MHz) 10

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 or to beating fetal hearts. 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. 11

BLOCK DIAGRAM 12

SPECIFICATIONS Probes: Model Freq. (multi freq.) BT2M20S8C 2 MHz BT4M05S8C 4 MHz BT5M05S8C 5 MHz BT8M05S8C 8 MHz BT10M5S8C 10 MHz Battery: DC 9 volts, Alkaline square type battery Battery life: Approx. 3 hours (Alkaline) Automatic shut-off Probe button: Power ON/OFF Speaker output: 200 mw or more External outputs: Headset Cuts off the speaker. (3.5 mm jack) Dimensions: Main unit: 78(W) x 142(D) x 27(H) mm Probe: 20(Diam.) x 105(L) mm Weight: Approx. 270 grams (including battery & probe) Electrical safety: Conform to IEC60601-1 Equipment with an INTERNAL ELECTRICAL POWER SOURCE Type BF applied part. Manufacturing date : The first 2 digits and following 2 digits of the serial number represent the year and month of manufacturing, respectively. The serial number is located inside of the battery compartment and it consists of 4 to 8 digits and may start with "Serial number" or "S/N". Examples: 03020001: Feb/2003 0401: Jan/2004 * Specifications subject to change 13

Accessories: (Optional) Carrying case Ultrasonic gel Battery Headset Camera strap CLEANING 1. PROBE Remove the Doppler gel from the probe head after use. Clean the probe using damp cloth and then wipe with a soft dry cloth, but take great care that any water may not penetrate into the probe. If using disinfectant, please consult in advance with the manufacturer. 2. 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. WARRANTY This equipment is guaranteed for a period of one year after the date of purchase when used under normal conditions. In the event of any trouble during the warranty period, please contact the dealer from who you purchased the unit. In case the warranty period is over, please consult the dealer for a charged service. 14

Hadeco, Inc. 7-11 Arima 2-chome, Miyamae-ku, Kawasaki, 216-0003 Japan 100VX OM E-26 August 25, 2004 Printed in Japan