: 0089 GTIN

Transcription

1 GTIN:

2 PRECAUTIONS PROBE Non-invasive probes are for transcutaneous use only Probe transducer tips are thin and delicate. Be careful not to drop or hit the probe tip. After use, protect the transducer with the probe cap. ULTRASOUND GEL Use ultrasound gel. Use of other materials such as baby oil and cream may not produce correct Doppler sound, and may damage the probe. Not recommended with patients having a sensitivity or allergic reaction to ultrasound gel. BATTERY When battery is low, the power indicator will flash. Replace the battery. Use only 9-volt alkaline batteries. A non-alkaline battery may cause a shortage of power. When not using the unit for a long period of time, remove the battery. MAIN UNIT Do not place near water or other liquid, where atmospheric pressure, ventilation, sunlight, dust, salt, sulfur, etc. may cause damage, or where chemicals are stored or gas may be generated. Use in environments where temperature is between C and humidity is less than 75%. Protect the unit from vibration and shock during transport. Keep more than 1.5 meters away from computers or other information equipment. Make sure that there is no damage to the unit or probe before use. Do not use simultaneously with an electro cautery defibrillator or other ultrasound device. Please do not use the Doppler continuously for more than 1 hour to avoid the possibility of skin irritation or rash. The Doppler box should not have direct patient contact or be placed in the sterile field as it cannot be sterilized and reprocessed. If contact occurs, please see cleaning instructions for cleaning the Doppler box. The Doppler box and non-invasive probes should be cleaned following any patient contact CAUTION: The ES-100VX has not been evaluated for safety and compatibility in the MR environment. The ES-100VX has not been tested for heating or migration in the MR environment. CAUTION: Perform ultrasound testing/procedures prudently using the principle of ALARA (As Low As Reasonably Acheivable)

3 TABLE OF CONTENTS ES-100VX MiniDoppler INTRODUCTION 1 CLINICAL APPLICATIONS...2 CONTROLS REPLACING THE BATTERY... 5 TURNING THE UNIT ON & OFF...5 OPERATION PROBE SELECTION...8 PRINCIPLES...9 BLOCK DIAGRAM...10 SPECIFICATIONS...11 CLEANING...12 WARRANTY...12 SAFETY STANDARDS

4 Thank you for choosing the ES-100VX MINIDOPPLER The ES-100VX MiniDoppler has four non-invasive interchangeable probe frequencies of 2.25, 5, 8, and 10 MHz for detection of arterial and venous blood flow in the lower extremities. The 2.25 MHz focused probe is for fetal heart rate measurement. FEATURES Pocketable, hand-held size Great sensitivity Wide probe selection for user flexibility Convenient probe activation button Automatic power off MiniDoppler is a registered trademark of Koven Technology, Inc., St. Louis, MO 1

5 CLINICAL APPLICATIONS The ES-100VX can be used for the following clinical applications: Fetal heart sounds Peripheral vascular procedures Pedal pulse checks Blood pressure segmental studies Venous compression studies 2

6 CONTROLS Front Panel 1) PROBE CONNECTOR To connect the probe to the Doppler 2) HEADSET CONNECTOR To connect a headset (not provided) 3) VOLUME CONTROL To adjust the sound volume 4) POWER INDICATOR Indicates power ON/OFF 5) SPEAKER Outputs Doppler sound 3

7 CONTROLS Rear Panel 6) PROBE HOLDER For probe placement when not in use 7) STRAP HOLES To connect the carry strap 8) BATTERY COVER See Replacing the battery on page 5 9) PROBE Choose from 2.25, 5, 8 & 10 MHz frequencies (8 MHz vascular & 2.25 MHz fetal are most common) 10) PROBE BUTTON Activates the ES-100VX 11) PROBE CAP Protects the probe tip when not in use 4

8 3. REPLACING THE BATTERIES REPLACING THE BATTERY Press down on the battery cover and slide in the direction of the arrow, as pictured on the right. Place a 9-volt alkaline battery in the unit, making sure that the positive and negative electrodes correspond to the + and marks on the label inside the battery box. Replace the battery when the power indicator LED flashes. NOTE: Use only 9-volt alkaline batteries. Use of non-alkaline batteries may cause a shortage of power. TURNING THE UNIT ON & OFF 1. TURNING THE UNIT ON Connect the probe with the arrow on the probe connector pointing up (12 o clock position) and press the probe button to turn the unit ON. Turn the volume control to the desired level. 2. TURNING THE UNIT OFF Press the probe button a second time to turn the unit OFF. 3. AUTOMATIC POWER OFF If the unit is left on while not in use, the power will be automatically shut off after approximately 3 minutes. NOTE: The auto-off time is dependent on room temperature. 5

9 OPERATION 1. Connect the probe to the ES-100VX with the arrow on the probe connector pointing up (12 o clock position). 2. Place ultrasonic gel on the probe tip or the patients skin. Make sure there is enough gel to cover the tip of the probe. Press the probe button to turn the unit on. 3. Make sure the power indicator on the unit is lit. Turn the volume control to the desired level. 6

10 OPERATION (cont.) 4. Place the probe on the skin and move slowly to locate the point where maximum Doppler sounds are heard (see below for your probe type). [Pencil Style Probe] If using the pencil style probe, hold the probe softly against the measurement area at an angle of approximately 45 to 60 degrees to the skin surface (see figure A) Figure A Figure B [Flat Vascular Probe (Model BF8)] If using the flat vascular probe, place the probe over the artery, adjust to locate the best sounds, and affix in place using the velcro strap provided (see figure B). [Fetal Probe (Model BT2M20S8C)] When using the 2 MHz probe for fetal heart beat detection, place the probe on the measurement area at a 90 degree angle (see figure C) and move slowly to locate the point where fetal heart sounds are at the maximum. Figure C 7

11 PROBE SELECTION The frequency of diagnostic ultrasound is inversely proportional to depth of penetration. The ES-100VX has 4 interchangeable non-invasive probes with different frequencies. Probe selection depends on the application. BT2M20S8C (2.25 MHz) (GTIN# ): Fetal heart beat & sounds BT5M05S8C (5 MHz) (GTIN# ): Deep peripheral blood flow BT8M05S8C (8 MHz) (GTIN# ): Superficial blood flow (most commonly used) BF8M15S8A (8 MHz) (GTIN# ): Superficial blood flow (flat probe) BT10M5S8C (10 MHz) (GTIN# ): Superficial blood flow APPLICATIONS 1. Detection of Fetal Heart Sounds Probes to be used: BT2M20S8C (2.25 MHz) Evaluation of fetal heart beat & sounds throughout pregnancy except where fetal heart is not developed sufficiently during the first trimester. 2. Detection of Arterial & Venous Blood Flow Probes to be used: BT5M05S8C (5 MHz) BT8M05S8C (8 MHz) (most commonly used) BF8M15S8A (8 MHz) (flat probe) BT10M5S8C (10 MHz) 8

12 PRINCIPLES The ES-100VX MiniDoppler is designed to receive blood flow velocity information through the use of ultrasound. A specific frequency is transmitted from the probe to the patient. The transceiver amplifies a high frequency oscillation output for transmission to the transducer. The voltage is converted by 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 amplify the signal, filters out noise and improves the S/N ratio. The Doppler shift signals are amplified further and converted to audible sound via the integrated speaker. 9

13 BLOCK DIAGRAM PROBE MAIN UNIT High Frequency Amplifier Wave Detection Band Pass Filter Low Freq. Output Transducers High Frequency Output High Frequency Oscilator Power Supply Speaker Headset 10

14 SPECIFICATIONS Probes: Model Freq. Multiple frequencies BT2M20S8C 2.25 MHz BT5M05S8C 5 MHz BT8M05S8C 8 MHz BT10M5S8C 10 MHz BF8M15S8A 8 MHz (flat) Battery: DC 9-volt, alkaline battery Battery life: Approximately 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 sound from the speaker (3.5 mm jack) Dimensions: Main unit: 78(W) x 141(D) x 27(H) mm Probe: 20(Diam) x 105(L) mm Weight: Approx. 270 grams (including battery & probe) Operating Environment: Storage and transport Environment: Electrical safety: degrees Centigrade ( degrees Fahrenheit) 85% humidity or less with no condensation 0-50 degrees Centigrade ( degrees Fahrenheit) 85% humidity or less with no condensation Conform to IEC Equipment with an INTERNAL ELECTRICAL POWER SOURCE Type BF applied part. Accessories: Carrying case Ultrasonic gel 9-volt battery Carry strap Optional Accessories: Doppler rollcart (CT-1) Not made with natural rubber latex * Specifications are subject to change 11

15 CLEANING DOPPLER BOXES AND NON-INVASIVE PROBES The Doppler box and probe can be wiped down using warm water, enzymatic cleaner, or alcohol with a damp soft cloth after use. If an enzymatic cleaner is used, wipe down again using warm water or alcohol with a damp soft cloth. Hospital approved alcohol based wipes are an acceptable alternative to a damp soft cloth. Caution: Do not submerge Doppler box or probe in any liquid. WARRANTY The Doppler box is warrantied for a period of 2 years from the date of purchase when used under normal conditions. Warranty periods on probes, adaptors & accessories vary. Please refer to your purchase invoice for additional warranty terms. In the event of an equipment malfunction during the warranty period, please contact Koven Technology, Inc. at or info@koven.com. The warranty does not cover defects resulting from accidents or misuse and is void if modifications or repairs are attempted without permission. In case the warranty period has expired, please consult Koven Technology, Inc. for a charge service. 12

16 SAFETY STANDARDS The ES-100VX conforms to the following standards: Guidance and manufacturer s declaration - electromagnetic emissions and immunity Guidance and Manufacturer s Declarations Electromagnetic Emissions The ES-100VX is intended for use in the electromagnetic environment specified below. The user of the ES-100VX should assure that it is used in such an environment. Emissions test compliance Electromagnetic environment - guidance RF emissions Group 1 The ES-100VX uses RF energy only for its internal function. Therefore, the RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment. RF emissions Class A The ES-100VX is suitable for use in all establishments other than domestic, and may be used connected to the CISPR 11 public low-voltage power supply network that supplies Harmonic Not Applicable buildings used for domestic purposes. IEC Voltage Not Applicable fluctuations/ flicker emissions IEC

17 Guidance and Manufacturer s Declarations (cont.) Electromagnetic Immunity The ES-100VX is intended for use in the electromagnetic environment specified below. The user of the ES-100VX should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic ± 6kV contact ± 6kV contact Floors should be wood, discharge (ESD) concrete or ceramic tile. If ± 8kV air ± 8kV air floors are covered with IEC synthetic material, the relative humidity should be at least 30%. Electrical fast ± 2kV for power Not Applicable transient/burst supply lines IEC ± 1kV for input/output lines Surge ± 1kV differential Not Applicable mode IEC ± 2kV common mode Voltage dips, short < 5% U T Not Applicable interruptions and (> 95% dip in U T ) voltage variations for 0,5 cycles on power supply 40% U T input lines (60% dip in U T ) for 5 cycles IEC % U T (30% dip in U T ) for 25 cycles < 5% U T (> 95% dip in U T ) for 5 s Power frequency 3 A/m 3 A/m Power frequency magnetic (50/60 Hz) fields should be at levels magnetic field characteristic of a typical IEC location in a typical commercial or hospital environment NOTE U T is the a.c. mains voltage prior to application of the test level. 14

18 Guidance and Manufacturer s Declarations (cont.) Electromagnetic Immunity (cont.) The ES-100VX is intended for use in the electromagnetic environment specified below. The user of the ES-100VX should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ES-100VX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3Vrms 3V d = 1,2 P IEC khz to 80 MHz Radiated RF 3V/m 3V/m d = 1,2 P 80 to 800 MHz IEC MHz to 2.5 GHz d = 2,3 P 800MHz to 2,5 GHz 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 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 affected by 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 access 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 ES-100VX is used exceeds the applicable RF compliance level above, the ES-100VX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ES-100VX b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m 15

19 Koven Technology, Inc. 477 N. Lindbergh Blvd., Suite 220 St. Louis, MO Tel: Fax: GLN: OM-1155 Copyright Koven Technology, Inc., St. Louis, MO