Bio Compression Systems Vascu-Ease IC-1200-WH User manual

REF IC-1200-WH
Instructions for Use
Quality Medical Products Since 1983

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Table of Contents
Introduction ...................................................................................................................3
Intended Use..................................................................................................................3
Device Description and Operating Principle............................................................... 3
Warnings and Precautions...........................................................................................5
Operating Instructions..................................................................................................6
Accessories...................................................................................................................9
Product Specifications .................................................................................................9
Environmental Specifications.................................................................................... 10
Symbol Glossary......................................................................................................... 14
Information for Distributors and Healthcare Providers ........................................... 15
Contact Information.................................................................................................... 15

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Introduction
Congratulations on the purchase of your Bio Compression Systems model IC-1200-WH
VascuEase Portable DVT System.
Package Contents
• IC-1200-WH intermittent pneumatic compression pumps
• Charger
• Instructions for use
• Garments
Intended Use
VascuEase is a prescription device intended for the prophylaxis of Deep Vein
Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of
venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic
edema and compartmental pressures. For use in home or hospital setting.
Contraindications
Use of this device is contraindicated for patients with any of the following conditions:
• Infections in the limb, including cellulitis, without appropriate antibiotic coverage
• The presence of lymphangiosarcoma
• Suspicion or confirmation of the presence of Deep Vein Thrombosis (DVT)
• Inflammatory phlebitis or episodes of pulmonary embolism
• Congestive Heart Failure (CHF)
• Pulmonary edema
• Severe arteriosclerosis or other ischemic vascular disease
• Any local condition of the extremity that would interfere with its application, including,
but not limited to: dermatitis, immediately following vein ligature, gangrene, skin grafts,
casts or splints
Device Description and Operating Principle
The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription
device intended for home or hospital use to help prevent post-operative DVT in patients
by stimulating blood flow as an aid in the prevention of DVT. The pump will inflate each
leg garment to a preset pressure and deflate after a period of time. The cycle continues
until the unit is turned off. Internal rechargeable batteries allow the VascuEase to be
completely portable, allowing for continued treatment without interruptions. Instructions
are provided for the patient to attach the garments and perform therapy at home.

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Guidelines for Treatment
A physician is required to prescribe these settings, but general guidelines are listed
below:
• Deep vein thrombosis (DVT) prophylaxis should be applied continuously, around the
clock, unless otherwise ordered by the attending physician. A less aggressive treatment
schedule is more commonly prescribed by the physician post discharge in the home
setting.
Front Panel and Key Features
Key Functions
1. Power On/Off Button
2. LED indicator
3. Pump valve
4. Charger port
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3
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Warnings and Precautions
US federal law restricts this device to sale by or on the order of a
physician.
Electrical Medical Equipment
• To avoid the risk of electric shock, burns, fire, injury, or improper treatment, read the
entire instruction manual before operating this device
• Use of accessories or a power cord not specified or provided by Bio Compression
Systems could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation
• Portable RF communications equipment (including cell phones and peripherals such
as antenna cables and external antennas) should be used no closer than 12" (30 cm) to
any part of the device including the power cord - otherwise, degradation of the
performance of this equipment could result
• Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation
Do Not Use
• For any contraindicated condition
• If the pump, accessories, or power cord are damaged or have been immersed in water
• With any accessories or power cord not specified or provided by Bio Compression
Systems
• In the presence of flammable anesthetics or in an oxygen rich environment
• In an MRI environment
• Near water, in a wet environment, or where aerosols are being sprayed
• For any use not described in this manual
Ask A Doctor Before Use If You Have
• Insensitive, irritated, injured skin, or skin conditions in/around treatment sites
When Using This Product
• Examine the device, accessories, and power cord for damage before using or cleaning
• Handle garments with care - do not fold or crease, use near a heat source, handle with
sharp objects, clean with abrasive materials, place in a washing machine or dryer, or
attempt to autoclave.
• Never share garments or use someone else’s garments - single-patient use only
• Do not carry or suspend the device using tubing, valves, or the power cord as handles
• Do not submerge the device or allow liquids to enter the device
• Never attempt to open, repair, or modify the device - no modification of this equipment
is allowed

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Stop Use And Ask A Doctor If
• Changes in skin appearance occur such as color changes, blisters, welts, or increased
swelling
• You feel burning, itching, increased pain, numbness, or tingling
In the event the pump stops working (e.g., power failure), release pressure by
disconnecting the garment.
Any serious incident that has occurred in relation to the device must be reported
to Bio Compression Systems. In the European Union (EU), incidents should also be
reported to the competent authority of the Member State in which the user and / or
patient is established.
Keep out of reach of children and pets.

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Operating Instructions
The patient is the intended user and can safely use all functions.
Preparing the Device for Use
• Remove garments and cardboard underneath from box
• Lift re-shipper box out of outer box and open
• Remove pumps and charger – save packaging for transport and storage
• Connect charger to pumps and plug into outlet
• Indicator light will be a steady yellow until pump is fully charged –a depleted battery
can take up to 4 hours to charge
• Assure pumps are fully charged before first use
• Remove garments from plastic bag, unroll, and spread flat
Connecting the Garments
• Firmly insert pump valve into garment input tube
• Attach pump to garment using Velcro on back
Putting the Garments On
• Snugly wrap sleeve marked “L” around left calf and sleeve marked “R” around right
calf –secure using Velcro fasteners
• Ensure air chamber is positioned at back of calf
Operating the Device
• Press “Power On/Off” button to turn on
• Indicator light will flash green – if it simultaneously flashes yellow, the battery is low
and must be charged
• Pump will inflate garment and hold for 15 seconds every minute until turned off with
power button
• If sleeve does not properly inflate in 3 minutes, pump will stop operating and alarm will
sound until power button is pressed or battery dies
• Should battery become low, an alarm will sound for 1 second each minute and
indicator will turn yellow
• Upon completion of treatment, press “Power On/Off” button to turn pump off
• Charge pumps for next use
• Upon the completion of treatment or to stop treatment, press “Power On/Off” button to
turn off
Reading the Usage Meter
Begin with device turned off. Press and hold the “Power On/Off” button for 10 seconds
until you hear a short beep. Release button and you will hear a long beep. The pump

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will then emit a series of short beeps to indicate the hours of use. For example, if the
pump emits 3 short beeps followed by 5 short beeps, that indicates 35 hours of use.
When complete, you will hear another long beep.
Cleaning
The pumps and garments can be wiped down using a damp (not wet) soft cloth while
unplugged –if pump disinfection is desired, use the following directions.
Pump disinfection
• Unplug and turn off
• Wipe down using a damp (not wet) soft cloth with mild antibacterial soap
• Air dry or pat dry using a soft cloth
• Wipe down using cotton balls moistened with 70% isopropyl alcohol
• Air dry for 30 minutes
Storing and Transporting
• Keep and reuse packaging for transporting the device
• Store in a dry location away from a source of heat and free of pests
Servicing and Repairs
• Contact Bio Compression Systems for servicing –there are no user serviceable parts
• Tampering, modifying, or dismantling this device in any way voids the warranty
• When contacting Bio Compression Systems, please have your model number and
serial number ready
Troubleshooting
Pump does not turn on:
1. Examine charger for damaged - if damaged, contact Bio Compression Systems
2. Plug in to see if pump is charging (solid yellow LED)
3. If not charging, check circuit breaker to make sure outlet has power
4. Contact Bio Compression Systems
Garment does not deflate:
1. Check garment connection to pump
2. Contact Bio Compression Systems
Low pressure alarm:
1. Make sure garment is snug
2. Check garment connection to pump
3. Check garment for damage
4. Contact Bio Compression Systems

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Pump does not charge:
1. Examine charger for damaged - if damaged, contact Bio Compression Systems
2. Plug in to check for solid yellow LED
3. If LED does not illuminate, check circuit breaker to make sure outlet has power
4. If LED does not illuminate or battery does not charge after 4 hours, contact Bio
Compression Systems
Accessories
REF
Description
GID-1000-PR
VascuEase DVT Garments

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Product Specifications
Models: IC-1200-WH
Electrical Input Rating: 120-240 VAC, 50-60 Hz, 0.7 A (max)
Electrical Classification: Class II
Type Applied Part: Type BF
Ingress Protection: IP22
Battery: 3.7 V Li-ion battery
Charge Time: 4 hours
Mains Isolation: Battery powered
Mode of Operation: Continuous
Essential Performance: The pump’s cyclical inflation and deflation of the garment(s)
Cycle Time: 60 ± 10 seconds (inflation 15 seconds, deflation 45 seconds)
Pressure: 50 mmHg
Accuracy: ± 20%
Features: Compliance/Usage Meter, Low Pressure Alarm, Low Battery Alarm
Warranty: Pump 6 months
Expected Service Life: 5 years
Software Safety Class: A
Regulatory Classification: AU IIa, CA 2, BR II, EU IIa, US 2
Weight: 0.5 lbs. (0.28 kg)
Dimensions: 5.1” x 2.7” x 1.6” (130 mm x 69 mm x 41 mm)

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Environmental Specifications
Consumables and Natural Resources Used During Care and Use
• Electrical energy for operation
• 1 drop of mild antibacterial soap and 2-3 cotton balls moistened with 70% isopropyl
alcohol - only as needed
• 70 mL laundry detergent and 250 mL bleach per 7.6 liters water for garment cleaning -
only as needed
Emissions During Normal Use
• Compressed air
• Minimal acoustic energy - nearly silent
• Minimal electromagnetic emissions - see manufacturer’s declaration and related
information below.
Instructions for Minimizing Environmental Impact
• Do not clean garment soiled - this minimizes the consumables used
• Reuse packaging for storing and transporting device
Operation Environment
• Intended for use in a healthcare or home environment
• Not intended of use in the presence of flammable anesthetics, an oxygen rich
environment, or an MRI environment
• Altitude up to 6561 feet (2000 m)
• Temperature 50-104° F (10-40° C)
• Humidity 30-75% RH
• Atmospheric pressure 700-1060 hPa
Transportation and Storage Environment
• Temperature 50-104° F (29-44° C)
• Humidity 30-75% RH
• Atmospheric pressure 700-1060 hPa
End of Life Management
• There are no components which contain stored electrical energy after the device has
been shut off
• Does not contain hazardous substances requiring special handling and treatment
• Dispose of the battery in accordance with the local regulations for lithium battery
disposal - batteries should never be thrown away or incinerated

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• Dispose of in an environmentally responsible manner in accordance with regional
requirements
• Contact Bio Compression Systems if you have questions or concerns regarding
disassembly and disposal
Manufacturer’s EMC Declaration
Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The
customer or user of the device should assure that it is used in such an environment.
Emissions
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its internal functions. 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 device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power supply
network that supplies building used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not
applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
applicable
Electromagnetic Immunity
Immunity Test
Immunity Test Level
Compliance Level
IEC 61000-4-2 Electrostatic Discharge
Immunity
±8kV Contact, ±2, 4, 8, 15kV Air
Discharge
±8kV Contact, ±2, 4, 8, 15kV Air
Discharge
IEC 61000-4-3 Radiated RF Field
Immunity
80MHz –2.7GHz: 10V/m, 80% AM at
1kHz
80MHz –2.7GHz: 10V/m, 80% AM at
1kHz
IEC 61000-4-3 Proximity Fields from
RF Wireless Communications
Equipment
IEC 60601-1-2, Section 8.10, Table 9
IEC 60601-1-2, Section 8.10, Table 9
IEC 61000-4-4 Electrical Fast
Transients
±2kV (Power), ±1kV (Signal), 100kHz
Repetition Frequency
±2kV (Power), ±1kV (Signal), 100kHz
Repetition Frequency
IEC 61000-4-5 Surge Immunity
±0.5, 1, 2kV Line-PE, ±0.5, 1kV Line-
Line
±0.5, 1, 2kV Line-PE, ±0.5, 1kV Line-
Line
IEC 61000-4-6 Conducted RF
Immunity
3V: 150kHz - 80MHz, 6V in Amateur
Radio & ISM Bands, 80% AM at 1kHz
3V: 150kHz - 80MHz, 6V in Amateur
Radio & ISM Bands, 80% AM at 1kHz
IEC 61000-4-8 Magnetic Field
Immunity
30A/m, 50 or 60Hz
90A/m, 50 or 60Hz
IEC 61000-4-11 Voltage Dips
0% UT/ 0.5 Cycles, 0% UT/ 1.0
Cycles, 70% UT/ 25/30 Cycles
0% UT/ 0.5 Cycles, 0% UT/ 1.0
Cycles, 70% UT/ 25/30 Cycles
IEC 61000-4-11 Voltage Interruptions
0% UT/ 250/300 Cycles
0% UT/ 250/300 Cycles

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Symbol Glossary
Authorized Representative in
the European Community
Manufacturer
Atmospheric pressure limitation
Medical Device
Batch code (lot number)
Keep dry
Catalog number
Power on/off (stand-by)
Caution
Refer to instruction manual/
booklet
Class II equipment (protection
against electric shock)
Restricted to sale by or on the
order of a physician
Complies with the Waste
Electrical and Electronic
Equipment Directive
(WEEE Directive)
Serial number
Complies the European Medical
Device Regulation
Temperature Limit
Date of manufacture
This way up
Fragile, handle with care
TÜV SÜD Certification Mark
(safety tested and production
monitored)
Humidity limitations
Type BF Applied Part
IP22
Ingress protection (protection
against solids up to 12.5 mm
and dripping water when tilted
up to 15°)
Warning: Electricity

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Information for Distributors and Healthcare Providers
Resetting the Pump
The pump remembers user settings and therefore it is important to reset the pump to its
original factory settings when placing the device on a new patient. To reset the usage
meter and return the pump to factory settings:
• Begin with pump turned off
• Press and hold the power button for 30 seconds
• You will hear a series of beeps then at 30 seconds you will hear 4 quick beeps the
LED will flash green.
• Release the power button
Contact Information
Manufacturer
Bio Compression Systems, Inc.
120 West Commercial Avenue
Moonachie, NJ 07074, USA
Phone: [phone]
Toll-Free Phone (US): 800-888-0908
E-mail: [email protected]
Website: www.biocompression.com
When contacting us, please have your model number and serial number ready.
Authorized European Representative
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands

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L-226 K EN 2020-07