Cooper surgical Summit doppler lifedop l300ac User manual

International

Phone: +1 (203) 601-9818

Fax: +1 (203) 601-4747

www.coopersurgical.com

EMERGO EUROPE

Prinsessegracht 20

2514 AP The Hague

The Netherlands

Made in the USA

EC REP

95 Corporate Drive

Trumbull, CT 06611 USA

Phone: (800) 243-2974

Fax: (800) 262-0105

Summit Doppler™ LifeDop® User Manual

ABI Vascular System

L300AC

This page left blank intentionally This page left blank intentionally

24 1

Thank you for choosing Summit Doppler products. We believe you have purchased the

nest 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!

Table of Contents: Page

Intended Use/Contraindications/Warnings . . . . . . . . . . . . . . . . 2

Safety of Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Installation and Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . 5

Controls, Indicators & Connectors . . . . . . . . . . . . . . . . . . . . . . 6

Performing the ABI Examination . . . . . . . . . . . . . . . . . . . . . . . .8

Interpreting the Examination Results . . . . . . . . . . . . . . . . . . . . 13

Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Replacing LifeDop®Batteries . . . . . . . . . . . . . . . . . . . . . . . . . .17

Recharging Printer Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Troubleshooting Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Verication of Printer Switch Settings . . . . . . . . . . . . . . . . . . . . 20

Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Please read the manual carefully and become familiar with the operation, features and

maintenance of your Doppler prior to using the device or accessories.

Year of manufacture

is located on the device.

CooperSurgical, Inc.

95 Corporate Drive

Trumbull, CT 06611 USA

Here’s how you can reach us...

Phone: (800) 243-2974

Fax: (800) 262-0105

International

Phone: +1 (203) 601-9818

Fax: +1 (203) 601-4747

Service and Repair

(800) 444-8456 or +1 (203) 601-9818 for international calls

www.coopersurgical.com

Explanation of Symbols

REF

Only

LATEX

EC REP

Reorder Number

Consult instructions for use

Caution: U.S. Federal law restricts this device to sale by or on the order of a licensed

practitioner

Date of Manufacture (located on device)

Serial Number

Not made with natural rubber latex

Authorized Representative in the European Community

Manufacturer

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.

Keep Dry

Type B Applied Part

Class II Equipment

Caution

LifeDop®and Summit DopplerTM are trademarks or registered trademarks of CooperSurgical, Inc.

Fujitsu and the Fujitsu logo are trademarks or registered trademarks of Fujitsu Limited in the United States and other

countries.

CooperSurgical is a registered trademark of CooperSurgical, Inc.

CooperSurgical provides general reimbursement information related to the diagnosis of

peripheral arterial disease as an overview for our customers. It is important to understand

that reimbursement is a complex process and requirements are subject to change without

notice. It is the responsibility of the healthcare provider to determine and submit appropriate

codes, charges, and modiers for services that are rendered. Prior to ling any claims,

customers are advised to contact their third-party payers for specic coverage, coding

and payment information. CooperSurgical makes no promise or guarantee of

reimbursement by Medicare or any other third-party payer.

Intended Use

This product will be used to detect blood ow 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

There are no known Contraindications associated with the use of this device.

Warnings

• The vascular probes 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.

• This device is not intended for use with HF surgical equipment.

General Warnings

Warnings

• The LifeDop® L300 ABI is for use by qualied personnel only. Read the User Manual

before use.

• Carefully route all cables and tubing to reduce the possibility of patient entanglement or

strangulation.

• Do not plug any part of this device into a telephone or modem.

• Do not use equipment that is damaged or malfunctioning. Seek appropriate service when

needed. Inspect equipment regularly for signs of damage. Use alternate equipment if

needed.

• Do not connect Luer ttings from Summit Doppler equipment into any other equipment.

If there are questions or concerns regarding these warnings, please do not hesitate to

contact CooperSurgical for further clarication.

Warranty and Servicing Policy

This product is warranted to be free from defects in materials and workmanship for 12

months from the original sale of the device. Product life is specied to be 5 years from

manufacture, though the device may be repairable beyond this timeframe. This includes all

parts and labor required to repair or replace the unit to original specications and shipping

costs associated with sending the product back to the customer. Customer is responsible

for providing adequate packaging materials and shipping costs to CooperSurgical. Products

shall be repaired or replaced in a reasonable amount of time.

CooperSurgicals’ liability for any claim is limited to materials and labor associated with repair

or replacement. In no event shall CooperSurgical be liable for incidental or consequential

losses or damages in connection with the purchase of this product.

CooperSurgical disclaims all express or implied warranties, agreements or arrangements

other than issued in this warranty.

CooperSurgical is not responsible for damages to the device that occur as a result of the

inadequate packaging on return shipments to CooperSurgical, improper maintenance or

cleaning as described in the user manual, misuse, abuse, alteration of the equipment from

its original specications, or dismantling the unit (other than by CooperSurgical approved

service technicians).

Service Returns – To return products:

1) Call CooperSurgical for any nal instructions prior to shipping.

2) Clean the product before shipping.

3) Ensure the product is well packaged and suitable for shipment.

Send the product to:

Repair Department

CooperSurgical, Inc.

95 Corporate Drive

Trumbull, CT 06611 USA

For Service and Repair, please call: (800) 444-8456 or +1 (203) 601-9818 for international calls.

22 3

Safety of Ultrasound

The Summit Doppler LifeDop L300 ABI System was 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. The following o󰀩cial statements from the American

Institute of Ultrasound Medicine (AIUM) are provided for your general information regarding the

safe use of ultrasound.

The following o󰀩cial 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 benets and

recognized e󰀩cacy 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 conrmed biological e󰀨ects on patients or instrument operators caused by exposures

from present diagnostic ultrasound instruments. Although the possibility exists that such biological

e󰀨ects may be identied in the future, current data indicate that the benets to patients of the

prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present.

Safety in Training and Research

Approved March 1997, March 1983

Diagnostic ultrasound has been in use since the late 1950s. There are no conrmed adverse

biological e󰀨ects on patients resulting from this usage. Although no hazard has been identied

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 benet 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.

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.

Application(s): Peripheral Vascular

Transducer Model: LifeDop 5 MHz Bi-Dir Operating Mode: Continuous-Wave (cw)

ACOUSTIC OUTPUT MI ISPTA.3 ISPPA.3

(mW/cm2) (W/cm2)

Global Maximum Value 0.04 365 0.37

Associated

Acoustic

Parameter

Pr.3 (Mpa) 0.116

Wo(mW) 15.7 0.016

fc(MHz) 8.43 8.43 8.43

Zsp (cm) 0.63 0.63 0.63

X-6 (cm) 0.42 0.42

y-6 (cm) 0.14 0.14

Az (cm) 0.6

Ele. (cm) 0.3

Beam Dimensions

EBD

ISPTA.3 the derated spatial-peak temporal-average intensity (mwatts per cm2).

ISPPA.3 the derated spatial-peak pulse-average intensity (watts per cm2).

MI the Mechanical Index.

Pr.3 the peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the

value reported for MI.

Wothe total time-average ultrasonic power (mwatts).

fcthe probe center frequency (MHz).

Zsp the axial distance at which the reported parameter is measured (cm).

X-6, y-6 are the –6dB beam dim. in the x-y plane where zsp is found (cm).

EBD the entrance beam dimensions (cm). These dimensions are the same as the dimensions of the transmit

crystal.

Measurement Uncertainties: Power: +34, -42%

Pressure: +11, -16%

Intensity (Ispta): +23, -26%

Frequency: ± 5%

Acoustic Output Parameters are measured in water. Derated values, denoted by the subscript “.3”, take

into account a conservative level of attenuation that would be encountered in the human body. The

derated intensity values (I.3) are obtained from water values of intensity (Iw) at a depth of z calculated

by:

I.3 = exp(-0.23*0.3*f*z)*Iw

(where f is the probe frequency in MHz and z is the depth in centimeters)

The derated peak rarefactional pressure is calculated from the value of measure water (pr) by:

Pr.3 = exp(-0.115*0.3*f*z)*pr

(where pressure is given in megapascals)

Additional Output Reporting Information for IEC 61157

8 MHz: Iob < 112 mW/cm2

Note that parameter Zsp in the probe reporting tables is the same parameter as Ipin IEC 61157.

Operating Conditions: There are no user controls which a󰀨ect the ultrasound output.

4 21

Product Description

The LifeDop L300 ABI is a full-featured handheld Doppler designed to serve the needs

of clinicians performing the ankle brachial index (ABI) exam. Limb systolic pressures are

obtained with a highly sensitive bi-directional ultrasound Doppler probe. Each limb pressure

can be stored for calculation of the left and right ABIs. Doppler waveforms can be stored

for each ankle. Examination results are printed on a high-speed, battery-powered, portable

printer.

Main Unit

The L300 ABI main unit is a handheld Doppler with keypad for calculation of the ABI results.

This battery-powered unit is designed to provide the best possible detection of arterial blood

ow.

Doppler Probes

The L300 ABI uses bi-directional probes with 8 MHz (standard) or 5 MHz (optional) operating

frequency. Bi-directionality is the ability to discriminate arterial ow towards and away from

the probe, which is essential for proper display of the ankle waveforms.

The 8 MHz bi-directional probe (shallow penetration) is optimal for measuring the systolic

blood pressure in the extremities for most patients. For larger patients, an optional 5 MHz

probe is available.

The 5 MHz bi-directional probe o󰀨ers deeper penetration and a slightly wider beam, but is

actually less sensitive on shallow vessels than the 8 MHz probe.

The L300 ABI is powered by three AA alkaline batteries and is provided with a user

replaceable probe cable.

Portable Companion Printer

Exam results are printed on a high-speed battery-powered printer. This printer uses

thermally sensitive paper. Our standard paper is adhesive backed label paper. Label paper

makes 8.5 x 11 inch report generation fast and easy. The printer is powered by a lithium-ion

rechargeable battery and comes with its own recharger.

LifeDop Printer

Dimensions (h x w x l): 147 x 70 x 35 mm 136 x 84 x 43 mm

Weight: 320 grams 280 grams

Operating temperature: 10 to 30 °C 0 to 30 °C

Operating humidity: 30 to 75 % 20 to 85 %

Transport/Storage temp: –20 to 50 °C –20 to 60 °C

Transport/Storage humidity: 5 to 90%, non-condensing for both units

(beyond 30 days, battery to be stored between –20 and 30 °C)

LifeDop Printer

Battery life: 40, 12-minute exams 500 prints

Battery type and voltage: AA Alkaline 1.5 V x3 Lithium Ion 3.7 V

Audio bandwidth and power: 245 Hz – 4 KHz, 0.33 W

Printer Paper Type/Size (max): Thermal, 58mm wide, 33mm diameter

Printer Speed: 35 mm/sec, 8 sec for standard printout

Printer Resolution: 48 mm wide, 8 dots/mm, 384 dots/line

Printer Impact Resistance: 1.5 meter on linoleum oor

Printer Communication: RS232, 115.2K, 8/1, no parity

Printer Recharger: Input – 100 -120 VAC, 29 VA, 50/60 Hz

Output – 5 VDC, 2.3 A, center positive

Waveform Frequency Scale: Auto scaled to 4 KHz, 2 KHz and 1 KHz

Waveform Time Scale: 25 mm/sec, 100 mm w/ 4 sec of data

Printout Length: 38 mm total with header

Application(s): Peripheral Vascular

Transducer Model: LifeDop 8 MHz Bi-Dir Operating Mode: Continuous-Wave (cw)

ACOUSTIC OUTPUT MI ISPTA.3 ISPPA.3

(mW/cm2) (W/cm2)

Global Maximum Value 0.05 500 0.5

Associated

Acoustic

Parameter

Pr.3 (Mpa) 0.12

Wo(mW) 32.7 0.033

fc(MHz) 5.50 5.50 5.50

Zsp (cm) 0.85 0.85 0.85

X-6 (cm) 0.4 0.4

y-6 (cm) 0.6 0.6

Az (cm) 0.4

Ele. (cm) 0.8

Beam Dimensions

EBD

520

Installation and Basic Operation

Preparing the Equipment for Use

Recharge the printer before use. Plug the probe cable into the main unit, and become

familiar with the equipment’s capabilities and limitations by reading the LifeDop and Printer

User Manuals prior to use.

Connecting the Printer

Ensure that the printer is loaded with paper and connect the cable to the LifeDop and printer

as shown, with connector tabs down as labeled “THIS SIDE UP”. Turn the printer on by

HOLDING the power button down (approximately 3 seconds) until the LED comes on. If the

printer is functioning properly and ready to print, the LED will ash green twice every second.

Printer Connections

To disconnect the printer cable from the LifeDop, press the tabs on the edges of the

connector. On the printer end, the latching tab is on the back of the connector.

Caution

• Forcing the cable upside down will cause damage to the connector pins on the LifeDop,

cable and printer. Note the label “THIS SIDE UP”.

Note: When turning the printer on or o󰀨, it is important to remember to hold the button down,

approximately 3 seconds, before the printer will respond.

Cautions

• Install the paper roll in the printer

so the external side (heat sensitive

side) of the rolled paper is against

the print head (down).

• Do not use printer paper other than

the type specied and supplied by

CooperSurgical. Other paper types

could result in damage or degraded

print quality and may void the

warranty. Loading Paper

Printer Not Printing (Error 9)

The LifeDop and printer have lost communication. This may be due to a printer jam, paper

empty, low printer battery or any of the previously listed printer error codes. To clear

the error, lift the paper cover lever, reseat the paper roll and close the cover. If printer

communication is re-established, the LifeDop will automatically print the bu󰀨ered waveform.

If Error 9 persists, turn o󰀨 both printer and LifeDop and re-start waveform bu󰀨er.

Faint Signal is Audible, but Waveform is not Visible on Printout

The LifeDop main unit is designed to reject noise and certain artifacts. Even a valid signal

must reach a threshold before it can be printed; therefore it is normal for some very weak

signals to be rejected.

Verication of Printer Switch Settings

Caution

• Printer DIP switches are preset at the factory. The printer will not function properly if they

are moved from these set positions.

The printer switches have been preset at the factory to the proper location, however if they

have been changed the printer will not function. Orient the printer and set the DIP switches to

match the following:

Specications

Degree of protection against electric shock:

Type B Applied part

Class II Equipment

Degree of protection against ingress of water:

IPX4 – extending 2.5 cm from tip

IPX1 – entire probe 2.5 cm from tip, excluding connector

Designed and tested to meet:

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, EN 55011

Connect the LifeDop only to equipment that meets the appropriate standards.

1 – Up

2 – Down

3 – Down

4 – Down

6 19

Controls, Indicators & Connectors

On/O󰀨 Control

Turn the LifeDop L300 ABI on by pressing the On/O󰀨 button. LCD indicators show power

status. The LifeDop automatically shuts itself o󰀨 after 5 minutes if it is not being used, or

after 20 minutes if a limb pressure or ankle waveform has been saved.

Turn the printer on by pressing and holding the On/O󰀨 button until the green LED comes on

(approximately 3 seconds). Printer automatically shuts itself o󰀨 after 30 minutes.

Note: All stored data is erased when power is turned OFF. Always print before turning

o󰀨 the power.

Volume Slider

Adjust the audio level by sliding the volume control up or down.

Note: The volume slider does not change the headphone volume.

Site

Press the SITE key to change the active storage location shown on the display. Each key

press advances the storage location one time. Available sites are presented in the order that

an ABI exam is often conducted, including Right Brachial Pressure (R-BRA), Right Ankle

Waveform (R-WAV), Right Ankle Pressure (R-ANK), Left Ankle Waveform (L-WAV), Left

Ankle Pressure (L-ANK), and Left Brachial Pressure (L-BRA). There also two ABI sites, L

and R. (See also Site Location Indicator below)

Press the PRINT key to print all stored data. Printing will begin immediately if the printer is

enabled and connected. If the printer is not on-line, the display will show “Prn” and printing

will commence as soon as the printer is on-line.

Volume

On/O󰀨

Site

Numbers

Troubleshooting Problems

Warnings

• Use alternate equipment in case of unit failure. Call the CooperSurgical Service

Department if the probe or main unit malfunctions at (800) 444-8456 or +1 (203) 601-9818

for international calls.

• Do not drop or mishandle the LifeDop, probes, aneroid or other accessories. Damage

to sensitive electrical components, speakers, cables, transducers or plastic is likely to

occur.

Poor Sound Quality

• Inadequate gel use

• Try and relocate the probe for a better signal

• Improper choice of probe frequency

• Interference from other equipment

• Probe coiled cable or battery contacts may be intermittent

• Debris in the speaker may cause poor sound

• Device damage from dropping the LifeDop, probes or accessories

Battery Indicator Flashing on LifeDop

Replace batteries as described above.

Radio Frequency Interference

The LifeDop was tested for immunity to electromagnetic interference at a level of 3 V/meter.

Interference during normal operation may occur in the presence of elds stronger than 3

V/meter. If this occurs, try increasing the distance between the LifeDop and the source of

interference. Contact CooperSurgical for more information.

Printer Self-Test

The printer will perform a self-test by turning the printer on while the feed button is being held

down. A checkered test pattern will print in addition to the printer conguration and loaded

fonts.

Printer LED Red or Orange

Green Orange Red

LED LED LED Error Solution

Flash 2x No Error Normal

Flash Low Battery Recharge

Flash 1x Out of Paper Reload Paper

Flash 2x Open Cover Close Cover

Flash 3x Thermal Failure Call CooperSurgical

Flash 4x Voltage Failure Call CooperSurgical

Probe Connector

Headphone Jack

Printer Connector

Store Waveform

Clear

18 7

ABI/Pressure Data

Battery Indicator

Site Locations

Flow Direction

Keypad Numerals 0-9

Enter each limb’s systolic pressure data using the numeric keypad. The pressure is stored

in the site location shown on the display. Once the pressure is entered the unit automatically

advances to the next site location.

Clear (Below Numeral 0)

Pressing the clear button erases the pressure or waveform stored in the currently selected

SITE location.

Site Location Indicator

When ashing, the site location indicator denotes that the current site location does not

contain data. The current site location stays on to denote that data has already been stored

in that location.

Flow Direction Bar Graphs

The ow direction bar graph provides a visual aid for acquiring the Doppler waveform.

The number of segments that are displayed is proportional to the velocity of the blood ow.

The arrows pointing to the left indicate ow going towards the probe tip. The arrows pointing

to the right indicate ow going away from the tip.

Battery Icon

When ashing, the battery icon indicates that the LifeDop’s batteries are low and should be

replaced.

Store Waveform

Press the red button on the side of the LifeDop L300 ABI to store Doppler waveforms in

either the Left Ankle (L-ANK) or Right Ankle (R-ANK) site locations. The display will show

“Str” to indicate that an ANK site contains stored data.

Probe Connector

Plug the probe cable into the top connector on the side panel.

Headphone Connector

Connect headphone (32 ohm). Flow coming toward the probe is heard in the left side, ow

going away from the probe is heard in the right side.

Recharging Printer Batteries

Caution

• Use only the battery and AC adapter supplied with the printer. Use of any other battery

and or AC adapter is hazardous and may cause damage to the equipment.

Warning

• Do not connect the printer to the Doppler while the printer is charging.

It is recommended that the printer be recharged

prior to rst use. Turn the printer o󰀨. Lift the

rubber ap on the left side of the printer and plug

in the connector of the recharge adapter.

Make sure recharger is plugged into a standard

120 VAC outlet. When properly connected, the

LED will be red. Upon completion of charging

the LED will turn o󰀨. Remove the recharger and

replace the rubber ap.

Accessories

To order accessories (gel, batteries, cables, carrying case, user manual, printer paper,

forms etc.), please contact CooperSurgical at (800) 243-2974 or +1 (203) 601-9818 for

international calls.

Periodically (at least annually):

Inspect the main unit and probes for signs of cracks or breaks in the mechanical housing.

Inspect cables and connectors for signs of wear or failure. The user should discontinue use

of the unit with any sign of loss of housing integrity. Contact CooperSurgical for service at

(800) 444-8456 or +1 (203) 601-9818 for international calls.

Replacing Batteries

Caution

• If the unit is to be stored for longer than 90 days without use, remove the batteries prior

to storage.

• It is recommended that the printer’s rechargeable batteries be replaced annually.

• Replace batteries only with batteries supplied by CooperSurgical. The battery

compartment only accepts AA size batteries. See the Accessories list for part numbers

and re-order information.

• Be sure to follow any local, state and/or national requirements when disposing of used

batteries.

Open the battery compartment by depressing the tab and pulling outward on the battery

door. Remove the existing drained batteries by pushing on the end of the battery that

compresses the battery contact spring and lift upwards. It is acceptable to use a small tool or

pen to assist in this step

Replace the batteries by paying close attention to

the polarity indicators on the battery and the polarity

indicators on the battery holder in the compartment.

Positive (+) aligns with positive (button) and negative

(-) aligns with negative (spring). Insert the battery such

that the spring contacts are loaded rst and then press

the battery rmly into place.

Warning

• If the batteries have been inserted incorrectly, the unit will not function but the LifeDop

will not be damaged.

Performing the Ankle Brachial Index (ABI) Examination

The ABI for each leg is determined by dividing the ankle pressure by the higher of the two

arm pressures. Doppler waveforms from the ankles aid in the diagnosis of PAD and are

usually required for reimbursement.

Note: To avoid losing data during the exam, do not turn the LifeDop o󰀨 until the

results are printed. Replace batteries (LifeDop) or recharge (Printer) before

beginning the exam if needed.

1. In a warm room, have the patient take o󰀨 shoes and socks and rest in a supine position

for approximately 5 minutes prior to taking pressures. Patient should wear thin, loose

tting clothing. Avoid rolling up sleeves or pant cu󰀨s in such a manner that it obstructs

blood ow [1]. Bulky items such as sweaters should be removed.

2. Wrap the cu󰀨s snuggly around the arms and ankles as shown in Figures 1 and 2.

The edge of the cu󰀨 should be placed approximately 1 to 2 inches above the site

of examination. Select the proper cu󰀨 width, equivalent to 40% of the patient’s limb

circumference. In general, average sized adults use 10 cm cu󰀨s, while larger adults use

12 cm cu󰀨s [1].

Figure 1 Figure 2

While applying the cu󰀨s, it may be a good time to explain the examination to the patient and

answer any questions he/she may have during this period.

Right Brachial Artery Pressure

3. Connect the hose from the hand pump to the cu󰀨 on the right arm. Apply a small amount

of gel over the patient’s brachial artery on the right arm and place the Doppler probe

at approximately 45 degrees, pointing in the direction toward the shoulder as shown in

Figure 3. Slide the probe laterally across the arm to nd the brachial artery and obtain the

best signal possible.

Figure 3

4. Find a stable and comfortable position to brace the probe hand while quickly inating the

cu󰀨 20 mmHg above the occlusion pressure, at this point Doppler sounds are no longer

heard. Be sure that the Doppler probe stays on the artery during ination [2].

5. Deate the cu󰀨 at approximately 2 mmHg per second by gently squeezing the pressure

release trigger on the aneroid. Listen for the blood ow sounds to return. When the ow

sounds return, this is the systolic pressure. Once this pressure is obtained, rapidly deate

the remaining pressure in the cu󰀨 [2].

6. Use the LifeDop’s keypad to enter the pressure for the R-BRA site. The site will

automatically advance to the R-ANK location after the brachial pressure is stored.

916

Maintenance and Cleaning

Warnings

• The LifeDop is not designed for liquid immersion. Do not soak the Doppler main unit or

probes in liquids. Do not use products containing bleach.

• The LifeDop is not designed for sterilization processes such as autoclaving, gamma radiation

or hydrogen gas.

• Do not allow water or spray to enter through the connectors or speaker grill.

• The LifeDop is not intended to be used on open skin. If there is evidence of open wound

contamination, disinfect the probe before using again as described below.

• Examiners should wash hands and change gloves after every exam.

• Follow temperature and humidity guidelines as specied in the Specications section.

The LifeDop Doppler requires very little maintenance. However, it is important to continuing

function of the unit and the health of the patients that the unit is cleaned and examined

regularly per the following guidelines:

Cleaning and Disinfection Process for Probes and Remotes

1. Devices should be cleaned as soon as possible. Do not allow soil to dry on the device. If

cleaning cannot be performed immediately, keep device moist.

2. Moisten a disposable wipe with water. Remove excess gel and other visible soil from probe

and remote. In particular, pay close attention to the seams along plastic lines.

Do not allow water or spray to enter the connectors or other electrical components.

3. Prepare an enzymatic, neutral pH cleaner solution: dilute chemistry in accordance with

Manufacturer’s instructions.

4. Immerse a clean, lint-free wipe into cleaning solution and wring excess moisture. Thoroughly

wipe the probe only for a minimum of 30 seconds, paying particular attention to seams.

Discard the wipe.

5. Repeat step 4 with a new, clean wipe a minimum of one time or until all visible soil has been

removed. Discard the wipe between successive repeats. (Do not place soiled wipe into

cleaning solution.)

6. Immerse a new, clean, lint-free wipe into the cleaning solution and wring excess moisture.

Wipe the remote and electrical cord for a minimum of 30 seconds. Discard the wipe.

7. Immerse a new, clean, lint-free wipe into warm (25-30 °C) utility water and wring excess

water. Thoroughly wipe the remote and electrical cord rst for a minimum of 30 seconds

followed by the probe for an additional 30 seconds. Discard the wipe.

8. Repeat step 7 one time with a new, clean, lint-free wipe.

9. Use a sterile 70% IPA wipe, or a low-lint wipe, saturated with sterile 70% IPA, to thoroughly

wipe the remote and electrical cord rst, followed by the probe.

10. Wipe the remote, electrical cord, and probe dry with a new, clean, lint-free wipe.

11. Once dry, visually inspect the device for any residual soil. Repeat cleaning instructions if

visible soil is present.

Right Ankle Waveform

7. Acquire a Doppler signal at either the posterior tibial (PT) or dorsalis pedis (DP) artery as

shown below. Start by applying a small amount of gel to the site and tilt the probe at a 45

degree angle, pointing the probe tip toward the calf and knee. Slide the probe across the

general location of the artery until the best signal is obtained.

Normal patients will usually have tri-phasic or bi-phasic ankle waveforms. Patients with

peripheral arterial disease (PAD) will have reduced ow which results in a waveform with

fewer changes in ow direction. Often with these patients the signal will be mono-phasic,

meaning the ow is always in one direction.

Right DP Right PT

8. Maintain the best signal possible for a minimum of 4 seconds and press the red button on

the side of the LifeDop to store the waveform in the R-WAV location. The site location will

show “Str” and then automatically advance to R-ANK.

Storing the Right Waveform

Abnormal Ankle Waveforms - Monophasic

These waveforms have no reverse ow component and minimal pulsatility.

References for the ABI Exam:

[1] Human Blood Pressure Determination by Sphygmomanometery: American Heart

Association (AHA), 2001

[2]

Techniques in Noninvasive Vascular Diagnosis – an Encyclopedia of Vascular Testing;

Daigle RJ, Summer Publishing, 2002: 137-148

[3] Olin JW. Clinical Evaluation and O󰀩ce-Based Detection of Peripheral Arterial Disease,

contained in Primary Care Series: Peripheral Arterial Disease and Intermittent

Claudication; Hirsch AT (Ed), Excerpta Medica, Inc., 2001

[4] ACC/AHA Guidelines for Management of Patients with Peripheral Arterial Disease, 2005.

10 15

The Doppler waveforms are automatically scaled to a maximum frequency of either 1 KHz, 2

KHz or 4 KHz for optimal waveform height. Markings on the vertical axis are provided every

1 KHz. Printer calibration is not required.

Auto-Scaling - 1 KHz, 2 KHz and 4 KHz

Blood ow in the direction toward the probe is shown above the baseline. Flow away

from the probe is shown below the baseline. Two traces are provided so that ow in both

directions can be displayed simultaneously.

Sample Doppler Waveforms

Normal Ankle Waveforms – Triphasic

The waveforms are pulsatile with forward and reverse ow.

Right Ankle Pressure

9. Connect the cu󰀨 hose to the right ankle cu󰀨. Use either the PT or DP artery to obtain

the ankle systolic pressure. Acquire the Doppler signal. Brace your probe hand while

inating the cu󰀨 to a pressure 20 mmHg above the occlusion pressure, which is the point

at which ow sounds are no longer heard. Be sure to keep the probe on the artery while

inating.

10. Deate the cu󰀨 at 2 mmHg/sec by gently squeezing the pressure release trigger on the

aneroid. Be sure not to move the probe. Listen for the blood ow sounds to return – this

is the systolic pressure. Note the pressure when ow returns, then rapidly deate the

cu󰀨.

11. Use the LifeDop’s keypad to enter this pressure in the R-ANK site. The site location will

automatically advance to the L-WAV location.

Note: Some protocols call for obtaining pressures from both the DP and PT arteries and

using the higher of the two pressures in the calculation of the ABI. In this case

obtain both pressures and then enter the higher of the two in the R-ANK location.

Completing the Exam for the Left Side

12. Obtain the Doppler waveform from the patient’s left ankle (DP or PT artery) and use the

red button to store in the L-WAV location.

Left PT Left DP

13. Move the hose to the left ankle cu󰀨. Take the left ankle pressure from the DP or PT and

enter the systolic pressure from the L-ANK location using the keypad.

Determining the Pressure at the Left PT

14. Move the hose to the left arm cu󰀨. With the Doppler probe on the brachial, obtain the left

arm pressure and enter this value at L-BRA.

1114

Viewing and Printing the ABI Results

15. The ABI for the left leg is displayed after the L-BRA pressure is entered. The ABI for the

right leg can be seen by pressing the SITE key once.

16. Press the PRINT key to print the results. The display will show “Prn”. Printing will begin

immediately if the printer cable is connected and the printer is on. Otherwise the LifeDop

will continue to display “Prn” until the printer is connected and on.

Warnings

• The print head becomes hot during printing. Do not touch the print head after printing.

• Turn o󰀨 the printer and check that the head is fully cooled before attempting to x a

paper jam, replacing paper, or removing the print roller for any reason.

17. Cut the printed data into three sections at the indicated markings. Peel the back from

each section of label paper and stick the pressures and two waveform strips.

ABI for the Right Side

Interpreting the Examination Results

Ankle Brachial Index

The ankle-brachial index (ABI) is determined by dividing the ankle pressure by the higher of

the two brachial pressures. A separate ABI is determined for each leg. These calculations

are done automatically by the LifeDop L300 ABI.

ABI = ankle pressure

higher brachial pressure

For example:

Right brachial: 120 mmHg

Left brachial: 126 mmHg

Right ankle: 145 mmHg

Left ankle: 92 mmHg

Right ABI = 145 = 1.15

126

Left ABI = 92 = 0.73

126

An ABI less than 0.9 is considered abnormal. The following interpretation levels are based

on the 2005 AHA/ACC PAD Guidelines:

Doppler Waveforms

Waveforms are interpreted by examining the combination of rise time, fall time, presence of

reverse ow components, and height. Normal waveforms have relatively fast rise- and fall-

times and are multiphasic (i.e one or more reverse ow components). With PAD the rise-and

fall-times are lengthened, the reverse ow components are lost, and the height is diminished.

ABI Interpretation levels

> 1.4 Noncompressible

1.00 – 1.4 Normal

0.91 – 0.99 Borderline

0.41 – 0.90 Mild-to-moderate PAD

0.00 – 0.40 Severe PAD

12 13

Viewing and Printing the ABI Results

15. The ABI for the left leg is displayed after the L-BRA pressure is entered. The ABI for the

right leg can be seen by pressing the SITE key once.

16. Press the PRINT key to print the results. The display will show “Prn”. Printing will begin

immediately if the printer cable is connected and the printer is on. Otherwise the LifeDop

will continue to display “Prn” until the printer is connected and on.

Warnings

• The print head becomes hot during printing. Do not touch the print head after printing.

• Turn o󰀨 the printer and check that the head is fully cooled before attempting to x a

paper jam, replacing paper, or removing the print roller for any reason.

17. Cut the printed data into three sections at the indicated markings. Peel the back from

each section of label paper and stick the pressures and two waveform strips.

ABI for the Right Side

Interpreting the Examination Results

Ankle Brachial Index

The ankle-brachial index (ABI) is determined by dividing the ankle pressure by the higher of

the two brachial pressures. A separate ABI is determined for each leg. These calculations

are done automatically by the LifeDop L300 ABI.

ABI = ankle pressure

higher brachial pressure

For example:

Right brachial: 120 mmHg

Left brachial: 126 mmHg

Right ankle: 145 mmHg

Left ankle: 92 mmHg

Right ABI = 145 = 1.15

126

Left ABI = 92 = 0.73

126

An ABI less than 0.9 is considered abnormal. The following interpretation levels are based

on the 2005 AHA/ACC PAD Guidelines:

Doppler Waveforms

Waveforms are interpreted by examining the combination of rise time, fall time, presence of

reverse ow components, and height. Normal waveforms have relatively fast rise- and fall-

times and are multiphasic (i.e one or more reverse ow components). With PAD the rise-and

fall-times are lengthened, the reverse ow components are lost, and the height is diminished.

ABI Interpretation levels

> 1.4 Noncompressible

1.00 – 1.4 Normal

0.91 – 0.99 Borderline

0.41 – 0.90 Mild-to-moderate PAD

0.00 – 0.40 Severe PAD

12 13

The Doppler waveforms are automatically scaled to a maximum frequency of either 1 KHz, 2

KHz or 4 KHz for optimal waveform height. Markings on the vertical axis are provided every

1 KHz. Printer calibration is not required.

Auto-Scaling - 1 KHz, 2 KHz and 4 KHz

Blood ow in the direction toward the probe is shown above the baseline. Flow away

from the probe is shown below the baseline. Two traces are provided so that ow in both

directions can be displayed simultaneously.

Sample Doppler Waveforms

Normal Ankle Waveforms – Triphasic

The waveforms are pulsatile with forward and reverse ow.

Right Ankle Pressure

9. Connect the cu󰀨 hose to the right ankle cu󰀨. Use either the PT or DP artery to obtain

the ankle systolic pressure. Acquire the Doppler signal. Brace your probe hand while

inating the cu󰀨 to a pressure 20 mmHg above the occlusion pressure, which is the point

at which ow sounds are no longer heard. Be sure to keep the probe on the artery while

inating.

10. Deate the cu󰀨 at 2 mmHg/sec by gently squeezing the pressure release trigger on the

aneroid. Be sure not to move the probe. Listen for the blood ow sounds to return – this

is the systolic pressure. Note the pressure when ow returns, then rapidly deate the

cu󰀨.

11. Use the LifeDop’s keypad to enter this pressure in the R-ANK site. The site location will

automatically advance to the L-WAV location.

Note: Some protocols call for obtaining pressures from both the DP and PT arteries and

using the higher of the two pressures in the calculation of the ABI. In this case

obtain both pressures and then enter the higher of the two in the R-ANK location.

Completing the Exam for the Left Side

12. Obtain the Doppler waveform from the patient’s left ankle (DP or PT artery) and use the

red button to store in the L-WAV location.

Left PT Left DP

13. Move the hose to the left ankle cu󰀨. Take the left ankle pressure from the DP or PT and

enter the systolic pressure from the L-ANK location using the keypad.

Determining the Pressure at the Left PT

14. Move the hose to the left arm cu󰀨. With the Doppler probe on the brachial, obtain the left

arm pressure and enter this value at L-BRA.

1114

Right Ankle Waveform

7. Acquire a Doppler signal at either the posterior tibial (PT) or dorsalis pedis (DP) artery as

shown below. Start by applying a small amount of gel to the site and tilt the probe at a 45

degree angle, pointing the probe tip toward the calf and knee. Slide the probe across the

general location of the artery until the best signal is obtained.

Normal patients will usually have tri-phasic or bi-phasic ankle waveforms. Patients with

peripheral arterial disease (PAD) will have reduced ow which results in a waveform with

fewer changes in ow direction. Often with these patients the signal will be mono-phasic,

meaning the ow is always in one direction.

Right DP Right PT

8. Maintain the best signal possible for a minimum of 4 seconds and press the red button on

the side of the LifeDop to store the waveform in the R-WAV location. The site location will

show “Str” and then automatically advance to R-ANK.

Storing the Right Waveform

Abnormal Ankle Waveforms - Monophasic

These waveforms have no reverse ow component and minimal pulsatility.

References for the ABI Exam:

[1] Human Blood Pressure Determination by Sphygmomanometery: American Heart

Association (AHA), 2001

[2]

Techniques in Noninvasive Vascular Diagnosis – an Encyclopedia of Vascular Testing;

Daigle RJ, Summer Publishing, 2002: 137-148

[3] Olin JW. Clinical Evaluation and O󰀩ce-Based Detection of Peripheral Arterial Disease,

contained in Primary Care Series: Peripheral Arterial Disease and Intermittent

Claudication; Hirsch AT (Ed), Excerpta Medica, Inc., 2001

[4] ACC/AHA Guidelines for Management of Patients with Peripheral Arterial Disease, 2005.

10 15