Summit Doppler LifeDop L250 Series User Manual

Summit Doppler LifeDop L250 Series User Manual

L150 series (handheld doppler without display), l250 series (handheld doppler with display)

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User Manual for LifeDop
®
L150 Series (Handheld Doppler without Display)
L250 Series (Handheld Doppler with Display)
REF
L150, L150A, L150R, L250, L250AR, L250R,
MC150, MC150R, MC250, MC250R
MAN0001-DFU • Rev. A • 11/12
Wallach Surgical Devices

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Summary of Contents for Summit Doppler LifeDop L250 Series

  • Page 1 User Manual for LifeDop ® L150 Series (Handheld Doppler without Display) L250 Series (Handheld Doppler with Display) L150, L150A, L150R, L250, L250AR, L250R, MC150, MC150R, MC250, MC250R MAN0001-DFU • Rev. A • 11/12 Wallach Surgical Devices...
  • Page 2: Table Of Contents

    ® Thank you for choosing LifeDop Doppler products. We believe you have purchased the finest handheld Doppler on the market today. Your total satisfaction is our highest priority as we strive to continually improve our products and services. Please contact us with any suggestions. We look forward to enjoying a long-term relationship with you! Wallach Surgical Devices Year of manufacture...
  • Page 3: Intended Use/Contraindications/Warnings

    Intended Use Obstetric (2 and 3 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular (4, 5 and 8 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
  • Page 4 Ultrasound Medicine (AIUM) are provided for The following official statements from the American Institute of your general information regarding the safe use of ultrasound. Clinical Safety Approved March 1997, October 1982 Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: There are no confirmed biological effects on patients or instrument operators caused by exposures from...
  • Page 5: Description Of Product

    Description of Product The LifeDop Doppler is factory configurable to include many different features and product enhancements. Along with user interchangeable ultrasound transducers, the LifeDop Doppler device is well suited to meet your specific needs. Main Unit The main handheld unit is ergonomically designed to fit the palm of your hand with comfort and allow easy access to each control feature.
  • Page 6 Probes LifeDop Doppler ultrasound transducers were designed to meet your specific applications needs. Each probe has been ergonomically designed for comfort while providing excellent maneuverability for locating the fetus or vascular target. Each probe is carefully measured and tested to ensure it meets exacting performance standards. 2 MHz - Late term obstetrical examination.
  • Page 7: Operation And Installation

    Operation and Installation MAN0001-DFU • Rev. A • 11/12 Wallach Surgical Devices...
  • Page 8 LCD Panel for Display Units Only Turning Unit On/Off Turn the unit on by pressing the On/Off button. LED or LCD indicators (depending on the model) indicate power status. The LifeDop automatically shuts itself off after 3 minutes if it is not being used. This complete power shutdown preserves the life of the batteries and ensures the unit will be ready for operation in case it was accidentally left on.
  • Page 9 Battery Monitoring All LifeDop Doppler units perform continuous battery monitoring and give a visual indication of battery level. Display units use a multiple level battery shaped indicator that indicates the voltage level of the battery. The battery outline will flash when the battery level is very low indicating that the user should change the batteries soon after the current examination is complete.
  • Page 10 Play and Record (Recorder units only) Caution: To distinguish between live audio and playback audio refer to the Play indicator or Play LED. If the indicator is on, the sound is coming from a recorded signal. Play To listen to a pre-recorded audio file on the LifeDop Doppler, press and release the Play/Record button on the side of the unit.
  • Page 11 Download to Personal Computer (L150A and L250AR only – PC Sound Card Required) Warnings • The audio/headphone output should only be connected to external line powered accessories that comply with recognized safety standards such as IEC601-1, IEC60065, UL2601-1 or UL544. •...
  • Page 12 ® For use with Apple computers (Please note: SimpleSound is a program associated with OS 9 or earlier operating systems. For OS X or later operating systems SimpleSound may not be included) 1. To download the audio to a PC for permanent storage, connect one end of the provided 3.5 mm audio cable into the Audio Out jack on the side of the LifeDop.
  • Page 13: Obtaining Doppler Signals

    Obtaining Doppler Signals Caution • Doppler examinations should be performed only by trained individuals. For any Doppler examination, it is essential that an adequate supply of coupling gel is used to transmit the ultrasound energy from the probe to the surface of the skin. Re-apply more gel if it starts to dry out or spread so thinly that an air gap occurs between the probe and the skin.
  • Page 14 Obstetrical (continued) Many times when attempting to detect the fetal heart, the maternal vascular sounds are heard instead of (or in some cases, in addition to) the fetal sounds. These maternal sounds can come from one of the major arteries, the placenta or the umbilical cord. The maternal vascular sounds are typically higher in frequency at a lower rate.
  • Page 15: Maintenance And Cleaning

    Maintenance and Cleaning Warnings • The LifeDop is not designed for liquid immersion. Do not soak the Doppler main unit or probes in liquids. Use only spray or wipe cleaners and disinfectants. Do not use products containing bleach. • The LifeDop is not designed for sterilization processes such as autoclaving, gamma radiation, or hydrogen gas.
  • Page 16: Replacing Batteries

    Replacing Batteries Cautions • Replace batteries only with batteries supplied by Wallach Surgical Devices. See the Accessories section for reordering of parts information. • The battery compartment only accepts AA size batteries. See the Accessories section for reordering of parts information. Open the battery compartment by depressing the tab and pulling outward on the battery door.
  • Page 17: Troubleshooting

    Troubleshooting Warning • Use alternate equipment in case of unit failure. Call Wallach Surgical Devices Service Department if the probe or main unit malfunctions. Caution • Do not drop or mishandle the LifeDop, probes or accessories. Damage to sensitive electrical components, speaker, cables, transducers or plastic is likely to occur.
  • Page 18: Clinical References

    Radio Frequency Interference The LifeDop was tested for immunity to electromagnetic interference at a level of 3V/meter. Interference during normal operation may occur in the presence of fields stronger than 3V/meter. If this occurs, try to increase the distance between the LifeDop and the source of interference. Contact Wallach Surgical Devices for more information.
  • Page 19: Specifications

    Specifications Degree of protection against electric shock: Type B Applied part Class II Equipment Degree of protection against ingress of water: 2 MHz Waterproof: IPX7 – entire probe and cable excluding connector All other probes: IPX4 – extending 2.5 cm from tip IPX1 –...
  • Page 20 Transducer Model: LifeDop 4 MHz Operating Mode: Continuous-Wave (cw) Application(s): Peripheral Vascular SPTA.3 SPPA.3 (mW/cm (W/cm ACOUSTIC OUTPUT Global Maximum Value 0.05 0.278 (Mpa) 0.07 (mW) 47.2 0.047 Associated Acoustic (MHz) Parameter (cm) (cm) Beam Dimensions (cm) Az (cm) 0.45 Ele.
  • Page 21 Obstetrical Probe Information: Model Number 2 MHz 3 MHz (mW/cm 19.6 17.0 SATA (max) (mW) 48.0 24.4 Effective Radiating Area (cm 2.45 1.57 Ultrasound Frequency (MHz) 2.1 MHz 3.2 MHz Pulse Duration Repetition Freq. the spatial-average temporal-average intensity (mwatts per cm SATA the derated spatial-peak temporal-average intensity (mwatts per cm SPTA.3...
  • Page 22: Warranty And Servicing Policy

    Warranty and Servicing Policy The warranty on this product is that it will be free from defects in material and workmanship for 24 months from the original sale of the device. Product life is specified to be 5 years from manufacture, though the device may be repairable beyond this timeframe.
  • Page 23: Explanation Of Symbols

    Product conforms to the Medical Device Directive 93/42/EEC Authorized Representative in the European Community. ® ® LifeDop , Summit Doppler and Wallach are trademarks of CooperSurgical, Inc. ® Medichoice is a registered trademark of Owens & Minor, Inc.

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