Summit Doppler LifeDop L150 Series User manual

MAN0001-DFU • Rev. A • 11/12 Wallach Surgical Devices
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
REF

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
95 Corporate Drive
Trumbull, CT 06611 USA
Here’s how you can reach us...
Phone: [phone]
[phone]
Fax: [phone]
e-mail us at: customerserv[email protected]
visit our website at: www.wallachsurgical.com
Table of Contents:
Page
Intended Use/Contraindications/Warnings............................................................................ 2
Description of Product........................................................................................................... 4
Operation and Installation ..................................................................................................... 6
Obtaining Doppler Signals ................................................................................................... 12
Maintenance and Cleaning ................................................................................................... 14
Replacing Batteries............................................................................................................... 15
Troubleshooting.................................................................................................................... 16
Clinical References............................................................................................................... 17
Accessories........................................................................................................................... 17
Specifications ....................................................................................................................... 18
Warranty and Servicing Policy............................................................................................. 21
Explanation of Symbols ....................................................................................................... 22
Please read the manual carefully and become familiar with the operation, features and maintenance of
your LifeDop prior to using the device or accessories.
(This CE mark excludes the Medichoice®models: MC150, MC150R, MC250, MC250R)
Year of manufacture
located on the device.
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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.
Caution
• U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner.
Contraindications
Warnings
• The vascular probes (4, 5 and 8 MHz) are not for fetal use.
• The ultrasound probes are not to be used on or near the eyes.
• The device is for use only on intact skin.
• Do not plug any part of this device into a telephone or modem system.
• This device is not intended for use with HF surgical equipment.
If there are questions or concerns regarding these warnings or contraindications, please do not hesitate to
contact Wallach Surgical Devices for further clarification.
Caution
• Dropping the LifeDop, probe or accessories may cause damage to the housing or electronics.
Safety of Ultrasound
LifeDop Dopplers were designed with physician and patient safety in mind. In early design phases all
potential hazards were eliminated or reduced to As Low As Reasonably Achievable (ALARA) by
adhering to good design practices and industry wide safety standards. Ultrasound procedures should be
performed with the ALARA principle in mind when delivering ultrasound energy into the body.
In order to preserve, protect and improve the quality of the environment, protect human health
and utilize natural resources prudently and rationally – do not dispose of waste electrical or
electronic equipment (WEEE) as unsorted municipal waste. Contact local WEEE disposal sites.
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The following official statements from the American Institute of Ultrasound Medicine (AIUM) are provided for
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
present diagnostic ultrasound instruments. Although the possibility exists that such biological effects may
be identified in the future, current data indicate that the benefits to patients of the prudent use of
diagnostic ultrasound outweigh the risks, if any, that may be present.
Prudent Use
Approved May 1999
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the
non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-
dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the
fetus or determine the fetal gender without a medical indication is inappropriate and contrary to
responsible medical practice. Although there are no confirmed biological effects on patients caused by
exposures from present diagnostic ultrasound instruments, the possibility exists that such biological
effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provide
medical benefit to the patient.
Safety in Training and Research
Approved March 1997, March 1983
Diagnostic ultrasound has been in use since the late 1950s. There are no confirmed adverse biological
effects on patients resulting from this usage. Although no hazard has been identified that would preclude
the prudent and conservative use of diagnostic ultrasound in education and research, experience from
normal diagnostic practice may or may not be relevant to extended exposure times and altered exposure
conditions. It is therefore considered appropriate to make the following recommendation:
In those special situations in which examinations are to be carried out for purposes other than direct
medical benefit to the individual being examined, the subject should be informed of the anticipated
exposure conditions, and of how these compare with conditions for normal diagnostic practice.
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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. Each unit is individually tested and inspected to ensure the highest
quality standards.
SSQ (available in all models) – Superior Sound Quality. Every LifeDop Doppler is designed with a state
of the art sound system that produces excellent sound quality and long-term reliability.
Recharge (available in model numbers with “R”) – We offer the ease of use of a rechargeable system or
the attractive cost of a non-rechargeable unit. Either way, the LifeDop Doppler battery system has been
designed with your long-term battery life needs in mind.
LCD Display (L250 Series models) – The LCD display (optional) allows you to view the fetal heart rate
in larger easy to read digits, monitor battery life and battery recharging, observe signal strength
indicators, Play/Record functions, and multiple diagnostic indicators that ensure your unit is functioning
at peak performance levels.
Units without LCD display incorporate bright, easy to read LED indicators that also allow you to monitor
battery life, battery recharging and Play/Record functions as appropriate to your unit.
Record (available in model numbers with “A”) – This unique built-in enhancement allows you to record
Doppler sounds during an examination and refer to these sounds for later evaluation, replay for parents or
colleagues, or download the audio to a PC for permanent storage or e-mail. NOTE: Downloading is
“allowed” in those models with “AR”.
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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. This probe frequency is typically used during the last
trimester for deep fetal positions associated with larger women. Waterproof versions of the 2 MHz probe
are available.
3 MHz – Early and general-purpose obstetrical examination. This probe frequency is a general use model
ideal for most stages of fetal examination. Fetal heart sounds can be heard as early as 12 weeks and
sometimes sooner depending on the position and size of the fetus.
4 MHz Broad – This unique peripheral vascular probe is ideal for quickly locating brachial, radial and
ankle arteries in the performance of Ankle/Brachial Index testing. The broad beam of the 4 MHz probe
allows the user to place the probe over the general location of the artery and with very little movement
find the vessel for fast blood pressure measurements.
5 MHz – This standard “pencil” style probe is an excellent vascular tool for locating deep specific vessels
in the peripheral vascular system. The narrow grip and small face of the probe make it ideal for
maneuvering for maximizing the signal.
8 MHz – This standard “pencil” style probe is an excellent vascular tool for locating shallow specific
vessels in the peripheral vascular system. The narrow grip and small face of the probe make it ideal for
maneuvering for maximizing the signal.
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Operation and Installation
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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.
Diagnostic Monitoring (LCD Display units only)
Once the unit is on, the LifeDop display units perform a series of diagnostic checks. The unit first checks
and temporarily displays the frequency of the probe that is being used. This display will not reappear
unless the probe is changed or the power is cycled, in which case the display will again temporarily
confirm the frequency of probe that is connected.
The unit then checks for proper internal operating temperature, battery voltage, reference voltage and
power supply voltage levels. If any of these characteristics are out of range, the display will show the
ERROR indicator and a failure code associated with the diagnostic error. Diagnostic functions are
periodically checked while the unit is on to ensure the Doppler is operating at peak performance. Refer
to the Troubleshooting section for a listing of failure codes.
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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.
Non-display units use the On/Off LED as a battery indicator by flashing at a low rate (approximately
once per second) when the battery level is low. Several exams can still be performed in this state of
operation. The battery indicator will flash at a higher rate (approximately twice per second) when the
battery level is very low. The user should change the batteries soon after the current exam is complete.
Recharging (Rechargeable units only)
Warnings
• Do not use any other wall adaptor unit other than that supplied with the LifeDop Doppler. Major
damage to electrical components is likely to occur. See the Accessories section for reordering of parts
information.
• Do not attempt to recharge alkaline batteries. Major damage to electrical components is likely to
occur.
It is recommended that the LifeDop Doppler to be recharged prior to first use. To recharge the unit, plug
the recharge jack from the wall adaptor into the unit’s recharge connector. For display units, the battery
shaped indicator will cycle in a repeated rising pattern to indicate the unit is recharging. For non-display
units, the Recharge LED will turn on.
The recharge cycle will be limited to 14 hours or until the maximum battery voltage level has been reached.
Once the recharge cycle has been discontinued normally, the LCD indicator or the Recharge LED will flash
at a low rate. The unit will not overcharge the batteries. If it determines that the batteries do not require
charging, the charge cycle will be interrupted after 30 seconds.
Recharge Jack from power
supply plugs into connector
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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. For display units, the Play indicator is on during playback. For non-display units,
the Play LED is on during playback. The recorded audio files are not re-processed for heart rate
calculation - heart rates must be determined manually in the play mode.
The unit will continue to play the recorded audio until either the end of the stored data, or until the
Play/Record button is pressed again. This will stop the playback audio and the unit switches back to real
time audio when the indicators turn off. Volume control remains functional during playback.
Record
To record a new audio file on the LifeDop Doppler, obtain the desired Doppler signal and press and hold
the Play/Record button until the Record LCD indicator or Record LED comes on (approximately 4
seconds). Once the indicator has turned on and the button is released, the Doppler signal will be stored
for 32 seconds or until the Play/Record button is pressed again. Either of these events will stop the
recording audio mode.
Recording a new audio file automatically overwrites any previous recording.
Audio Jack from cable plugs into output connector
(L250AR Only)
Press Button to play, hold 4 seconds to record
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