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Batch code (lot number)
Authorized European Representative
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague, The Netherlands
UK Responsible Person
Emergo Consulting (UK) Limited
Compass House, Vision Park Histon
Cambridge CB24 9AD, United Kingdom
Caution
D
Description and Use
This device is a segmented inflatable sleeve (“garment”) which is intended to be
connected to Bio Compression Systems’ Sequential Circulator pneumatic
compression pump. The pump cyclically inflates the garment’s segments
(“chambers”) in sequence from the distal end toward the trunk of the body,
increasing circulation on the limb worn. Refer to your Sequential Circulator
instruction manual for specific indications, additional precautions and warnings,
and other important information.
Warnings and Precautions
Do Not Use •If you have, or suspect you have, a blood clot, pulmonary embolism,
or deep vein thrombosis (DVT) •If you have thrombophlebitis •If you have
lymphangiosarcoma •If you have severe peripheral neuropathy or difficulty
sensing hot or cold. •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 •While sleeping
•For any use not described in the pump manual
Ask A Doctor Before Use If You Have •Heart, vascular, or circulatory problems
(e.g., congestive heart failure (CHF), ischemic vascular disease) •Insensitive,
irritated, injured skin, or skin conditions in/around treatment sites •An infection in
the limb or inflammation of the skin (e.g., cellulitis, erysipelas) •Edema or swelling
Ask A Doctor Before Use If You Are •Pregnant
When Using This Product •Examine the before using or cleaning •Handle with
care - do not fold or crease, use near a heat source, handle with sharp objects,
clean with abrasive materials, or place in a washing machine or dryer •Do not
stand or walk while wearing as this can cause a fall •Always wear clothing,
bandages, or stockings underneath garments for hygienic reasons and to avoid
irritation •Never share or use someone else’s garments - single-patient use only
•With a hot or cold compress, do not use for more than twenty minutes every two
hours •Avoid folding, pinching, or kinking tubing as this can obstruct air flow •Do
not wrap tubing around limb as this can restrict blood flow •Do not carry or
suspend the device using tubing or valves •Do not submerge or allow liquids to
enter the device •Never attempt to open, repair, or modify the device
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, release pressure by disconnecting
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.
Intended for use by adults. Keep out of reach of children and pets.
Operating and Care Instructions
Preparing the Device for Use •After removing from plastic bag, unroll, and
spread flat
Connecting the Garment(s) •Locate the connector bar at the end of garment
tubing •Line up numbers on connector bar with numbers on pump •Squeeze the
sides and insert into pump – you will hear a “click” when connected •If an 8chamber garment, locate the second connecter bar and repeat previous steps
•When using two garments, remove blocker bar(s) from pump and repeat
previous steps
Putting the Garment(s) On •Leg sleeve: unzip, place leg in and make sure heel
is back and down and toes are inside the sleeve, use straps to guide garment on,
pull up zipper to secure •Bio Pants: unzip, place legs in garment and make sure
heels are back and down and toes are inside the sleeve, use straps to guide on,
pull up zipper on each leg to secure •Bio Abdominal: unzip, place leg in garment
and make sure heel is back and down and toes are inside sleeve, use straps to
guide on, secure flaps, pull up zipper on leg to secure •Arm sleeve: slide arm
through larger opening, hand should be flat with fingers inside the sleeve •Arm &
Shoulder: slide arm through larger opening, use opposite arm to secure flaps.
Hand should be flat and fingers inside the sleeve •4-Chamber Vest: place head
through hole like a t-shirt and then secure flaps in front •Elite-8 Bio Vest (left or
right): Unzip, slide arm through larger hole, secure flaps, and then zipper in front.
Hand should be flat with fingers inside the sleeve •Elite-8 Bio Vest (bilateral):
Unzip, slide arm through first hole, slide arm through second hole, zipper in front.
Hand should be flat with fingers inside the sleeve •When using gel inserts, align
Velcro and press to attach before putting on.
Removing Garment(s) •At the end of treatment, squeeze sides of connector bar
and pull to disconnect garment from pump •Press garment to remove remaining
air until loose enough to remove •Unzip (if applicable) and remove garment
Cleaning •The garment and tubing can be wiped down using a damp (not wet)
soft cloth while disconnected from the pump – if more thorough pump cleaning
or garment disinfection is desired, use the following directions.
Tubing disinfection •Unplug and wipe down using a damp (not wet) soft cloth
with mild antibacterial soap as needed •Do not use bleach
Garment disinfection •Disconnect from pump and open to expose all sides
•Prepare 1/3 cup of laundry detergent per 1 gallon of warm water (20 mL laundry
detergent per 1 L water) in a sink or container large enough to hold the garment
•Place garment in solution but do not submerge or place connectors in water as
this will damage the device •Soak for 30 minutes with mild agitation every 5-10
minutes - hard to remove soil may require hand washing using a soft clean cloth
while garment is in solution •Rinse with warm water and allow to air dry •Repeat
previous steps using a solution of 1 cup of bleach per 1 gallon of warm water (60
mL bleach per 1 L warm water)
Troubleshooting (does not deflate or pressure seems low) •Check
connection to pump •Check tubing for damage, kinks, or twists •Check for
damage •Contact Bio Compression Systems – tampering, modifying, or
dismantling this device in any way voids the warranty
Environmental Specifications
Consumables and Resources Used •70 mL laundry detergent and 250 mL
bleach per 7.6 liters water for garment cleaning - only as needed
Instructions for Minimizing Environmental Impact •Do not clean garment
unless 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°F – 100°F (10°C – 38°C) •Humidity 30-75% RH •Atmospheric
pressure 700-1060 hPa
Transportation and Storage Environment •Temperature -20°F – 110°F (-29°C
– 43°C) •Humidity 30-75% RH •Atmospheric pressure 700-1060 hPa
End of Life Management •Does not contain hazardous substances requiring
special handling and treatment •Dispose of in a responsible manner in
accordance with regional requirements •Contact Bio Compression Systems if you
have questions or concerns regarding disassembly and disposal
Catalog number
ate of manufacture
L-257 C EN 2022-12
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