Bio Compression Systems BioArterial Plus User manual

1
Bio Compression Systems, Inc.
Quality Medical Products Since 1983
Arterial Blood Flow
Enhancement System
Model IC-BAP-DL
BioArterial Plus
U.S. BASED MANUFACTURER

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Table of Contents
Introduction ......................................................................................................... 3
Important Safety Information ............................................................................ 3
Symbol Definitions .............................................................................................. 3
Warnings .............................................................................................................. 3
Basic Safety Precautions ..................................................................................... 4
General Equipment Specifications ..................................................................... 4
Indications For Use ............................................................................................. 5
Contraindications ................................................................................................ 5
Systems and Components .................................................................................... 6
Controls and Display ........................................................................................... 6
Garment Specifications ....................................................................................... 6
Operating Instructions ........................................................................................ 7
Maintenance and Storage ................................................................................... 9
Cleaning/Disinfecting Instructions for Garments ............................................. 9
Packaging, Shipping & Storage ......................................................................... 10
Pump Enclosure .................................................................................................. 10
Environmental Specifications ............................................................................. 10
Fuse Replacement ............................................................................................... 10
Troubleshooting ................................................................................................... 11
Equipment Classification/Electrical Specifications .......................................... 12
EMC Manufacturer’s Declarations ................................................................... 12
Warranty Information ......................................................................................... 14
Repair Service Information ................................................................................ 14
Bio Compression Products Available ................................................................. 15

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INTRODUCTION
Congratulaons on the purchase of your BIO COMPRESSION SYSTEMS MODEL IC-BAP-DL BIO
ARTERIAL PLUS Arterial Blood Flow Enhancement System and garments.
The BIO ARTERIAL PLUS is an Intermient, Sequenal, Pneumac Compression System that se-
quenally compresses both the foot and calf in paents suering primarily from diabec foot ul-
cers or intermient claudicaon (leg pain primarily from decreased arterial circulaon).
The durable, high quality material used in the manufacturing of these products will ensure that you
experience long-lasng and uninterrupted performance.
Should any problem occur, you can feel condent that your pump and garments are backed by the
industry’s best warranty and customer service! For any quesons or for Technical Support simply
dial our toll free number:
Warranty repairs or adjustments will be performed in a mely manner with minimal inconvenience
to you. For this reason, it is important that you obtain a “Return Authorizaon” (RA Number) when
calling.
WARNINGS:
 Do not use in the presence of ammable anesthecs.
 Federal law restricts this device to sale by, or on the order of a licensed physician.
 Unless otherwise ordered by the physician pressure should not be set any higher than
120mmHg.
 Cauon must be exercised for paents with insensive, irritated, sunburned, bruised or
broken skin, or with skin condions such as skin cancer, dermas, eczema, or psoriasis
in/around treatment sites. Should changes in skin appearance occur such as blisters,
redness, discoloraon, welts, or other
noceable changes in the skin), or if burning, itching, increased swelling should occur,
disconnue use and consult with a physician.
 This device is not intended for use during sleep.
 Slip and fall hazard. Do not stand or walk while wearing garments.
 Consult your physician prior to use.
IMPORTANT SAFETY INFORMATION
SYMBOL DEFINITIONS
Symbol Explanation Location
Refer to Documentation before using and
servicing
On back of the device and
in Instruction Manual
Electric shock warning Instruction Manual
Class II Protection On back of the device
Type B—Applied Part On back of the device

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The BIO ARTERIAL PLUS SYSTEM is designed to deliver bilateral pressures of 120 mmHg for up
to 1 hour, 2 to 3 mes per day. The cycle mes provide sequenal compression to the limbs for
4 seconds (+/-0.5 sec) followed by a 16 second rest period, for a total cycle me of 20 seconds
and three cycles per minute.
BASIC SAFETY PRECAUTIONS
When using an electrical appliance, basic safety precauons should always be followed.
DANGER - This product contains electronic components.
WARNING - To reduce the risk of burns, re, electric shock or injury to persons:
 In the event of a power failure, disconnect the garment from the pump to release any
residual air and pressure in the garment.
 Use this product only for its intended use as described in this manual
 Do not use if damaged or defecve - if device has a damaged electrical cord or plug, has
been dropped or damaged in any manner, dropped into water, or if the product shows any
signs of deterioraon.
 Do not place near a heat source or water.
 Do not carry this device by the power cord or use the cord as a handle.
 Keep this device out of reach of children or pets.
 Do not take the pump, garment or tubing apart.
 Use only accessories that are recommended by Bio Compression Systems, Inc.
 Never use pins or other metallic fasteners with this product.
 Do not operate on a so surface such as a pillow or maress, or under a blanket or other
covering.
 Do not use where aerosols (spray) are being used or where oxygen is being administered.
 Read the enre instrucon manual before operang this device.
GENERAL EQUIPMENT SPECIFICATIONS
Model IC-BAP-DL - Bio Arterial Plus
DIMENSIONS: H X W X D (in inches)
5 x 12 x 8
WEIGHT: 7.5 lbs.
COMPRESSION TIME: 4 Seconds (+/-0.5 Seconds)
NON-COMPRESSION: 16 Seconds (+/-3.0 Seconds)
DELAY BETWEEN FOOT & CALF: 1 Second (+/-0.5 Seconds)

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INDICATIONS FOR USE
The Bio Arterial Plus Arterial Blood Flow Enhancement System is intended as an ad-
junct therapy for paents with ischemic disease of the lower extremies, due to one
or more of the following causes:
 Rest or Night Pain
 Ulcers
 Intermient Claudicaon
 Ischemia
 Small Vessel Disease
 Gra Failure
 Arteriopathic Wounds
 Angioplasty/Stent Failure
 Minor Amputaons
CONTRAINDICATIONS
 Undesirable venous and lymphac return (as with congesve heart failure)
 Deep vein thrombosis (suspected or present)
 Inammatory Phlebis
 Episodes of pulmonary embolism
 Sepsis in the limb/s
 Cellulis without appropriate anbioc coverage for at least 72 hours prior to
starng treatment
 Immediately following skin gras in/around treatment sites
 Pulmonary edema associated with congesve heart failure
 Acute thrombophlebis

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SYSTEM AND COMPONENTS
The BIO ARTERIAL PLUS system is comprised of the Controller/Pump along with a set of
bilateral garments with color coded tubing and contrasng style “quick” connectors.
CONTROLS AND DISPLAY
(A) Velcro-type aachment tab (FOOT)
(B) Velcro-type aachment tab (UPPER CALF)
(C) Velcro-type aachment tab (MID CALF)
(D) Tube connector to pump (FOOT)
(E) Tube connector to pump (CALF)
(F) Digital Display
(G) ON/OFF Buons
(H) Up & Down Pressure Buons
Garment Specicaons
Available Sizing
STANDARD: (APG-3045-FC S) WIDE: (APGW-3045-FC)
FOOT: Fits 8” to 12.5” FOOT: Fits 8” to 14.5”
MID-CALF: Fits 9.5” to 18” MID-CALF: Fits 11 to 25”
UPPER CALF: Fits 10.5” to 20.5” UPPER CALF: Fits 12” to 27.5”
Length adjusts from 12” to 20.5” on both sleeves.
B
C
A
B
C
A
Digital
Display
On/Off
Buttons
E
D
F G H
Up/Down
Buttons

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OPERATING INSTRUCTIONS
 Place the pump on a sturdy table or any other at surface close to where you will be sing.
The pump has non-slip rubberized feet on the boom. Placing anything under the pump
can cause the unit to slide or move.
 Make sure that your pump is plugged into a safe, properly secured, 110 V, AC outlet.
 Remove garment from plasc bags with color coded tubing and connectors aached to each
garment.
 Do not wear the garments directly over skin. Always wear light clothing underneath gar-
ments for hygienic reasons and to avoid irritaon. It is recommended that light bandages,
clean hosiery or stockinees be worn under treatment garments. Clothing should be free
of zippers, buons or other items that could rub and chafe the skin or damage the garment.
 Aaching one garment at a me, aach tubing connectors (on ends of tubing) to connectors
on face of pump.
NOTE: Connectors can only be aached in one way due to uniqueness of their design. By
pushing in rmly, a “clicking” sound will conrm that proper aachment has been
made.
 Aer aaching both garments to the pump aach them to your legs.
NOTE: See “System & Components” for tab locaons
 Place heel poron of garment on oor. Place heel of foot snugly into heel
poron of garment, depressing foam poron down with arch of foot. (See 1)
While pressing down with arch, pull le tab (A) across foot to aach snugly
(See 2 & 3)
 Pull up gently on garment, with the two upper tabs detached (See 4)
 Pull upper le tab (B) across leg ( just under knee) followed by upper
right tab and aach snugly (See 5)
NOTE: Be sure that black valve on back of garment is centered on the
mid to upper calf area.
 Repeat same procedure with mid tab (C)
 Repeat same procedure with other garment
1
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45

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NORMAL POWER-UP SEQUENCE
On a normal power-up sequence, the IC-BAP-DL Bio Arterial Plus will go through the following:
 Current Mode Seng will be displayed for three seconds.
 Current Pressure Seng will be displayed for four seconds.
 Unit will now start running as along as the Valve was stopped in the correcon locaon, other-
wise a twenty second countdown will start to allow the valve to rotate to the correct starng
posion.
MODE TYPES
The IC-BAP-DL can be set for a one hour cycle or connuous running.
When powering up the device, the display will show the current seng (either “1Hr” or “CON”) for
three seconds and then the current pressure seng.
To switch between the two modes, start with the device turned o. Press and hold the DOWN
buon and then momentarily press the power buon. Connue to hold the DOWN buon for
3 seconds unl the mode changes, then release the DOWN buon. The display will show the new
mode, then the current pressure seng, and the cycle will then begin.
SETTING DESIRED PRESSURE
To set the desired pressure, with the pump turned o, press and hold the UP and DOWN buons at
the same me, and momentarily press the POWER buon. As soon as the display shows - - -, the
pressure can be changed. There are two ways to exit the pressure seng mode:
 If the up or down buons are not pressed for ten seconds, the power-up sequence will begin.
 Once your desired pressure is set, hit the power buon and the power-up sequence will start
immediately.
HOUR METER
To display the internal hour meter, with the pump turned o, press and hold the UP buon, then
momentarily press the power buon. As soon as you see a leer in the le-hand digit, the buons
can be released, It does not maer what order the buons are released in. If the buons are con-
nuously held-down, the digits may not be fully viewable.
The le-hand digit will be a leer which corresponds to the following:
A= 0 - 999 hours
B. = 1000 - 1999 hours
C. = 2000 - 2999 hours
D. = 3000 - 3999 hours
E. = 4000 - 4999 hours
F. = 5000 - 5999 hours
The le-hand digit will be displayed for three seconds. It will then turn-o, and the remaining hours
will be displayed for three seconds. Aer that the power-up sequence will begin.
RESETTING HOUR METER
To reset the internal hour meter, the unit must be powered up and running.

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While the unit is running, press and hold the DOWN buon rst, then press and hold down the POWER
buon. Both buons must be held down together for ve seconds. If the DOWN buon is accidentally
released and the POWER buon is sll being pressed, the unit will turn o. Aer both buons have
been held down for ve seconds, the display will show “rES”. Some of the segments on the E and S will
not be visible unl the buons are released. As soon as the display shows the “rES”, both buons can
be released. The “rES’ will be displayed for three seconds and your internal mer will be reset.
MAINTENANCE AND STORAGE
Exterior Pump Case Cleaning Instrucons:
1. Clean the exterior case and tubing with a damp (not wet) cloth using mild soap and water soluon
once per month or as needed.
GARMENT CLEANING/DISINFECTING INSTRUCTIONS:
Disconnect garment from device.
2. Open garment to expose all sides either by separang Velcro type hook and loop or by unzipping
(depending on type of garment).
3. Cleaning soluon should consist of 1/3 cup of laundry detergent per 1 gallon of warm tap water.
Use either a large sink or plasc tub able to hold enough soluon (depending on size and quanty
of garments) to completely submerge the garment leaving the latch connector bars out of the wa-
ter.
4. Garment should be soaked for 30 minutes with mild agitaon every 5 to 10 minutes while keeping
it below water surface.
5. Thoroughly rinse garment with warm tap water and allow to air dry.
6. Harder to remove soil on surface of garment may require addional washing by hand with a clean
towel while submerged. Avoid using any abrasive materials such as scrubbing pads or chemicals
that could cause damage to the exterior surface of garment.
7. Re-Submerge garment for 30 minutes (with excepon of tubing connectors) in soluon consisng
of 1 cup of bleach per 1 gallon of warm tap water, again agitang garment every 5 to 10 minutes
while keeping garment below water surface. Rinse garment thoroughly with warm tap water and
allow to air dry. This completes the disinfecng step.
WARNING!
 Only an authorized technician may open the pump
 Before cleaning, unplug power cord from electrical outlet
WARNING!
 Do not allow liquids to enter the pump, as this can present an electrical hazard
 Always allow the pump to dry before using
 Do not use bleach on the pump
WARNING! DO NOT place garment in washing machine.
WARNING! DO NOT use the tubing or valves as “handles” for carrying, handing or storing
garment.
WARNING! Never allow the Latch Connectors to be submerged into the water. If water
enters the inside of the garment, damage may occur to the device.

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PACKAGING, SHIPPING & STORAGE
The Model IC-BAP-DL - Bio Arterial Plus is shipped in a specially designed corrugated, re-
usable carton with protecve end-caps that envelope each end of the pump, thereby sus-
pending the pump on all four sides within the carton. This packaging design prevents
damage to the pump when the carton is thrown or handled roughly by the carriers.
The device should be stored in a clean, dry area between 60 to 80 °F. However, short term
exposure to temperatures –20°F to +110°F will not harm the unit. To maximize the
pump’s life, me should be allowed for the pump to adjust to room temperature when it
has been exposed to extreme temperatures.
PUMP ENCLOSURE
The pump enclosure is constructed of “Cycolac” which is a trademark of General Electric.
UL FLAME RATING: Under le #E47016, the UL Test method of UL 94 @ 23°C resulted in a
Flammability Rang of (2.3 VO).
ENVIRONMENTAL SPECIFICATIONS
For transport and storage:
Ambient temperature: -20°F- +110°F (-29°C- +44°C)
Relave humidity: 30% - 75%
Atmospheric pressure: 700hPa to 1060hPa
For operaon:
Ambient temperature: +50°F- +100°F (+10°C - +40°C)
Relave humidity: 30% - 75%
Atmospheric pressure 700hPa to 1060hPa
FUSE REPLACEMENT
Occasionally power surges or wear and tear can result in a blown outer safety fuse located
in the rear of pump, adjacent to the power cord.
If your safety fuse blows out, call Technical Support for a replacement.
The safety fuse may be replaced by the user, provided it is replaced with an idencal type
(3.0 Amp FSL).
NOTE: The outer safety fuse is the only item serviceable by someone other than a Bio
Compression Systems technician at the factory. Bio Compression Systems tech-
nicians have been trained specically for the manufacturing and repair of all Bio
Compression Systems products.

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TROUBLESHOOTING
If the correcve acon does not solve the problem, then call Bio Compression Systems, Inc.
Be sure to have serial number available when calling for service.
NOTE: In addion to possessing proper tools and tesng equipment, authorized service per-
sonnel have access to all electrical schemacs, calibraon instrumentaon and criteria
and an inventory of authorized replacement parts.
When servicing, use only idencal replacement parts. Do not remove cover. Refer to
qualied service personnel.
Symptom Possible Cause Corrective Action
The device is not working.
No electricity. Check the electrical wall outlet to be sure that
the pump is plugged into the outlet correctly.
Check the circuit breaker to be sure there is
power to the outlet.
Power cord. Unplug the power cord and look for any
damage or defects.
Fuses. Check the outer fuse and replace if necessary as
instructed in the owners manual. Contact Bio
Compression Systems, Inc., (1-800-888-0908) if
this is a reoccurring problem.
One garment inflates but the
second one does not.
The second garment is not
receiving air.
Check the garment hoses for adequate connec-
tion to the device, kinks, punctures, twists and /
or folds.
The device is making strange
and/or loud noises.
Device is on a uneven or
unstable surface.
Move to a more stable surface.
An internal problem Contact Bio Compression Systems, Inc., for
repair.
Regardless of the pressure set-
ting the garments are applying
a very low pressure.
Defective Garment. Check the garment for adequate connection to
the device, leaks, kinks, punctures, twists and /
or folds.
An internal problem Contact Bio Compression Systems, Inc., for
repair.

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ELECTRICAL SPECIFICATIONS/EQUIPMENT CLASSIFICATION
The Model IC-BAP-DL Bio Arterial Plus interior components are “double insulated” and do
not require a “protecve ground.” The system is equipped with an 18 gauge, 2-wire, 10.
Power cord, secured through the pump casing with a Heyco strain relief brushing as well as
an addional “hold-down” clamp for added safety.
1. Class of protecon against electrical shock: CLASS II EQUIPMENT
2. The degree of protecon against electric shock: APPLIED PART-TYPE B
3. Mode: CONTINUOUS OPERATION WITH INTERMITTENT LOADING
4. According degree of protecon against ingress of water: IXP0
EMC Manufacturer’s Declaraon
Model IC-BAP-DL electromagnec emissions—manufacturer’s declaraon
The model IC-BAP-DL is intended for use in the electromagnec environment specied below. The customer or the user of the model IC-BAP-DL should assure that
it is used in such an environment.
Emissions test Compliance Electromagnec environment— guidance
RF emissions
CISPR 11
Group 1 The model IC-BAP-DL uses RF energy only for its internal funcons. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The model IC-BAP-DL is suitable for use in all establishments, including domesc establishments and
those directly connected to the public low voltage power supply network that supplies building used
for domesc purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage uctuaons / icker
emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaraon—electromagnec immunity
The model IC-BAP-DL is intended for use in the electromagnec environment specied below. The customer or the user of the model IC-BAP-DL should assure that
it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnec environment—guidance
Electrostac
discharge (ESD)
IEC 61000-4-2
± 2, 4, and6 kV contact
± 2, 4 and 8 kV air
± 2, 4, and6 kV contact
± 2, 4 and 8 kV air
Floors should be wood, concrete or ceramic
le. If oors are covered with synthec ma-
terial, the relave humidity should be at least
30%.
Electrostac
fast transient / burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input / output lines
± 2 kV
Not applicable
Mains power quality should be that of a
typical home use locaon.
Surge
IEC 61000-4-5
± 0.5 and 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 0.5 and 1 kV dierenal mode
Not applicable, no ground wire
Mains power quality should be that of a
typical home use locaon.
Voltage dips, short
interrupons and voltage
variaons on power supply
input lines
IEC 61000-4-11
<5 % UT (>95% dip in UT) for 0.5 cycles
40 % UT (60% dip in UT) for 6 cycles
70 % UT (30% dip in UT) for 30 cycles
<5 % UT (>95% dip in UT) for 5 s
<5 % UT (>95% dip in UT) for 0.5 cycles
40 % UT (60% dip in UT) for 6 cycles
70 % UT (30% dip in UT) for 30 cycles
<5 % UT (>95% dip in UT) for 5 s
Mains power quality should be that of a
typical home use locaon. If the user of the
model IC-BAP-DL requires connued opera-
on during mains power interrupons, it is
recommended that the model IC-BAP-DL be
powered from an uninterrupble power
supply or a baery.
Power frequency (50/60
Hz) magnec eld
IEC 61000-4-8
3 A/m 3 A/m The power frequency magnec elds should
be at the levels found in a typical home use
locaon.
NOTE: UT is the AC mains voltage prior to applicaon of the test level.

13
Guidance and manufacturer’s declaraon — electromagnec immunity
The model IC-BAP-DL is intended for use in the electromagnec environment specied below. The customer or the user of the model IC-BAP-DL should assure that
it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnec environment—guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 1000-4-3
3 Vrms
15 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communicaons equipment should be used no closer to any part of the
model IC-BAP-DL, than the recommended separaon distance calculated from the equaon appli-
cable to the frequency of the transmier.
Recommended separaon distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rang of the transmier in was (W) according to the
transmier manufacturer and d is the recommended separaon distance in meters (m).
Field strengths from xed RF transmiers, as determined by an electromagnec 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 higher frequency range applies.
Note 2: These guidelines may not apply to all situaons. Electromagnec propagaons is aected by absorpon and reecons from structures, objects and peo-
ple.
a Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theorecally with accuracy. To assess the electromagnec environment due to xed RF
transmiers, an electromagnec site survey should be considered. if the measured eld strength in the locaon in which the model IC-BAP-DL is used exceeds
the applicable RF compliance level above, the model IC-BAP-DL should be observed to verify normal operaon. If abnormal performance is observed, addional
measures may be necessary, such as re-orienng or relocang the model IC-BAP-DL.
b Over the frequency range 150 kHZ to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separaon distances between portable and mobile RF communicaons equipment and the model IC-BAP-DL
The model IC-BAP-DL is intended for use in an electromagnec environment in which radiated RF disturbances are controlled. The customer of user of the model IC
-BAP-DL can help prevent electromagnec interference by maintaining a minimum distance between portable and mobile RF communicaons equipment
(transmiers) and the model IC-BAP-DL as recommended below, according to the maximum output power of the communicaons equipment.
Rated maximum output power of
transmier
W
Separaon distance according to frequency of transmier
m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmiers rated at a maximum output power not listed above, the recommended separaon distance d in meters (m) can be esmated using the
equaon applicable to the frequency of the transmier, where p is the maximum output power rang of the transmier in was (W) according to the
transmier manufacturer.
Note 1: At 80 MHz, the separaon distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and reecon from structures, objects and people.

14
WARRANTY INFORMATION
You can feel condent that your product is backed by the best warranty in the
industry covering any and all malfuncons (including parts and labor) resulng
from component and/or manufacturing defects.
Compression Pump = 3 years from date of purchase / invoice
Sleeves/Garments = 1 year from date of purchase / invoice
Serial Number: ____________________________________
Date Purchased: ___________________________________
Local Representave/Dealer: ________________________
Phone Number: ____________________________________
FOR ALL REPAIR SERVICES PLEASE CALL TECHNICAL SUPPORT AT:
Bio Compression Systems, Inc.