Bio Compression Systems SC-2004-DL User manual

SEQUENTIAL CIRCULATOR
Operating Instructions
Quality Medical Products Since 1983

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Table of Contents
Introduction...............................................................................................3
Intended Use.............................................................................................3
Device Description and Operating Principle...........................................4
Warnings and Precautions.......................................................................7
Operating Instructions .............................................................................8
Accessories ............................................................................................13
Product Specifications...........................................................................15
Environmental Specifications................................................................16
Symbol Glossary ....................................................................................18
Information for Distributors and Healthcare Providers........................19
Contact Information................................................................................19

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Introduction
Congratulations on the purchase of your sequential circulator and
garments.
Package Contents
Sequential Circulator pump
Power cord
Instructions for use
Blocker bar
Garment(s) - possibly packed separately
Intended Use
Sequential Circulators are pneumatic compression devices intended for
either primary or adjunctive treatment of lymphedema, peripheral edema,
lipedema, venous insufficiency, and venous stasis ulcers. Sequential
Circulators are also intended for the prophylaxis. Intended for use in a
home or healthcare setting.
Contraindications
Compression IS NOT recommended in 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) unless controlled by medication
Other indications as identified by the treating physician
Guidelines for Treatment
A physician is required to prescribe these settings, but general guidelines
are listed below:
It is ultimately the physician’s responsibility to prescribe the setting and
it should be written on the prescription upon referral. Every patient is
unique and communication with the physician is important when setting
the pressure.
50 mmHg works well for most patients. However, a different pressure
might be prescribed for your personal need and tolerance.

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Presence of fibrotic tissue may require as much as 80 mmHg in order
to soften the fibrotic tissue and achieve reduction. Once the tissue is
soft, the compression can be readjusted to 50 mmHg.
Patients with a history of Congestive Heart Failure (CHF), which is
controlled with medication, should never be in a flat position while
pumping. They should be in a reclined position with elevated legs
during treatment. Their treatment regimen duration may be divided into
twice a day 30 minutes per treatment.
Patients with a history of Deep Vein Thrombosis with or without a filter
may require less compression. These patients will generally tolerate 40
mmHg. Patients with a filter may need to divide their treatment into
twice a day, 30 minutes per treatment. It is suggested that the provider
obtain a negative Doppler study from the physician for their records.
Device Description and Operating Principle
Sequential Circulators provide gradient pneumatic compression for the
treatment of lymphedema and associated venous disorders. Sequential
gradient compression helps to increase blood flow and move excess lymph
away from the affected area for clearance from the body. This device can
provide sequential (distal to proximal) inflation/deflation cycles of
compressed air at prescribed pressures. Pneumatic compression devices
are proven to reduce limb swelling associated with lymphedema, help close
up chronic ulcers, and act as a prophylaxis for Deep Vein Thrombosis
(DVT).
Adjustable Pressure
The pressure of the pump can be adjusted between 10 and 120 mmHg.
Pressure can be selected before treatment and adjustments can be made
during treatment.
Adjustable Cycle Time
The cycle time is the time it takes the pump to inflate and deflate the
garment. The cycle time can be adjusted from 60 to 120 seconds in 15
second intervals.

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Timed Treatment
The pump can be run continuously or the treatment time can be set
between 10 and 120 minutes in 5 minute increments.
Focus Therapy
Focus Therapy is used to help treat patients at the beginning of their
session in an area that requires more attention. Focus therapy doubles the
inflation time of two adjacent chambers (SC-2004-DL) or three adjacent
chambers (SC-2008-DL) during the first ten minutes of treatment.
Play/Pause
The “Play/Pause” button gives the patient the option to stop the pump in
the middle of a treatment session allowing them to use the bathroom or
attend to other needs. Timed treatments will run for the full treatment time
even if paused to ensure patient receives appropriate therapy.

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Treatment Compliance Meter
The pump records the hours of use.
Front Panel
1. LED Indicators
2. LED Display
3. UP Button
4. DOWN Button
5. SET Button
6. Power On/Off Button
7. PLAY/PAUSE Button
8. Garment Connector Bar Port
9. Auxiliary Connector Bar Port (shown with Blocker Bar)
The SC-2008-DL has two Garment Connector Bar Ports and two
Auxiliary Connector Bar Ports as shown below:

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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
While sleeping
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

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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, or
place in a washing machine or dryer
Do not stand or walk while wearing garments as this can cause a fall
Always wear clothing, bandages, or stockings underneath garments for
hygienic reasons and to avoid irritation
Never share garments or use someone else’s garments - single-patient
use only
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 operate pump on a soft surface, under a blanket or covering, or
near a heat source
Never adjust pump settings unless directed by a physician
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
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.
Operating Instructions
The patient is the intended user and can safely use all functions.

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Preparing the Device for Use
Remove garment(s) and cardboard underneath from box
Remove garment(s) from plastic bag, unroll, and spread flat
Lift pump out of box and remove protective end caps –save packaging
for transport and storage
Place pump on a flat sturdy surface –pump must be close enough for
the controls to be reached during use
Attach power cord and plug into outlet
Pump is set to run for one hour at 50 mmHg with 90 second cycle time
- to change settings or use Focus Therapy, see below
To Change Pump Settings or Use Focus Therapy
Begin with the pump turned off
Press and hold “SET” button for 5 seconds
“SEtUP” will appear in LED Display and “Pressure” LED indicator will
be lit
Use UP or DOWN button to adjust pressure and press “SET” button
when finished
“SEt” will appear in LED Display and “Cycle Time” LED indicator will be lit
Use UP or DOWN button to adjust cycle time and press “SET” button
when finished
“SEt” will appear in LED Display and “Treatment Time” LED indicator
will be lit
Use UP or DOWN button to adjust treatment time –to set on
continuous mode, press UP button until LED Display shows “COn”
Press “SET” button when finished – “SEt” will appear in LED Display
and “Focus Therapy” LED indicator will be lit
Use UP or DOWN button to select chambers for focus therapy or select
“off” to turn off
Press “SET” button when finished – “SEt” will appear in LED Display
and pump will turn off
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

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(SC-2008-DL only) Locate the second connecter bar and repeat
previous steps
When using two garments, remove blocker bar(s) and repeat previous
steps
Putting the Garment(s) On
Leg sleeve: unzip, place foot in and use straps to guide garment on,
pull up zipper to secure
Arm sleeve: slide arm through larger opening
Operating the Device
Sit in a comfortable reclined position with legs elevated within reach of
controls
Press “Power On/Off” button to turn on
The settings will appear on the LED display and the pump will start
To pause treatment or change pressure during treatment, see below
At the end of a timed treatment, your pump will turn off
To turn off the pump during a treatment, press the “Power On/Off”
button –“HOld” will show in the LED and then the pump will turn off
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
Pausing Treatment
To pause treatment, press “Play/Pause” button and “PAUSE” will
appear on the LED display
“HOld” will show in the LED display while the pump returns to its
resting position and then “PAUSE” will appear. The garment will then
deflate (remove garment using directions above)
Press “Play/Pause” to resume treatment – when using timed treatment,
the remaining time will appear on the LED display

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Changing Pressure During Treatment
While the pump is running, press and hold the UP button for 5 seconds
until you see the word “HOld” - let go of UP button
Once the pump returns to its resting position “SEt” and “PrES” will
show in LED display, the blue LED will light up under “Pressure” and
the current pressure setting will show
At this point you can adjust the pressure up or down
When you have reached your desired pressure, hit the “SET” button,
the word “SEt” shows in the LED’s and the pump begins to operate
again
To See Treatment Compliance Meter (Hours of Use)
Begin with the device turned off
Press and hold the “Play/Pause” button for 5 seconds
“C” will appear followed by the hours of use since the last reset
Information will be displayed until “Play/Pause” is hit again
To Check Pressure Setting While Pump is Running
Hold the Down button until the pressure setting and the letter “P” show
To Reset Your Device to Factor Settings and Clear Compliance
Meter
Press and hold the Up, Down, and Set buttons together for 5 seconds
until the compliance meter hours show on the LED Display. Let go of
the buttons and then hit the “SET” button. You will see “CLr” in the
LED Display and the LED will shut off.
Cleaning
The pump, garment, and tubing can be wiped down using a damp (not wet)
soft cloth while unplugged –if more thorough pump cleaning or garment
disinfection is desired, use the following directions.
Pump and Tubing Cleaning
Unplug and wipe down using a damp (not wet) soft cloth with mild
antibacterial soap as needed
Do not use bleach

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Garment Disinfection
Disconnect from pump and open to expose all sides
Prepare a solution of 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)
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. Check to see if the pump is plugged in
2. Unplug and examine power cord for damaged - if damaged, contact
Bio Compression Systems
3. 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. Check garment hose for damage, kinks, or twists
3. Check garment for damage
4. Contact Bio Compression Systems

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Pressure seems low:
1. Check garment connection to pump
2. Check garment hose for damage, kinks, or twists
3. Check garment for damage
4. Contact Bio Compression Systems
Device is loud or making strange noises:
1. Make sure pump is on a stable surface
2. Assure stable surface is free and clear of any loose object
3. Contact Bio Compression Systems
Accessories (SC-2004-DL)
REF
Description
GS-3035-S
4-Chamber Arm Sleeve - Small
GS-3035-M
4-Chamber Arm Sleeve - Medium
GS-3035-L
4-Chamber Arm Sleeve - Large
GS-3035-SH-S-L
4-Chamber Arm & Shoulder Sleeve - Small, Left
GS-3035-SH-S-R
4-Chamber Arm & Shoulder Sleeve - Small, Right
GS-3035-SH-M-L
4-Chamber Arm & Shoulder Sleeve - Medium, Left
GS-3035-SH-M-R
4-Chamber Arm & Shoulder Sleeve - Medium, Right
GS-3035-SH-L-L
4-Chamber Arm & Shoulder Sleeve - Large, Left
GS-3035-SH-L-R
4-Chamber Arm & Shoulder Sleeve - Large, Right
GV-3000
4-Chamber Vest
GS-3045-H
4-Chamber Leg Sleeve - Half
GS-3045-S
4-Chamber Leg Sleeve - Small
GS-3045-M
4-Chamber Leg Sleeve - Medium
GS-3045-L
4-Chamber Leg Sleeve - Large
GN-3045-S
4-Chamber Narrow Leg Sleeve - Small
GN-3045-M
4-Chamber Narrow Leg Sleeve - Medium
GN-3045-L
4-Chamber Narrow Leg Sleeve - Large
GW-3045-H
4-Chamber Wide Leg Sleeve - Half
GW-3045-S
4-Chamber Wide Leg Sleeve - Small
GW-3045-M
4-Chamber Wide Leg Sleeve - Medium
GW-3045-L
4-Chamber Wide Leg Sleeve - Large
GXW-3045
4-Chamber Extra Wide Leg Sleeve
GA-3045-H
4-Chamber Adjustable Leg Sleeve - Half
GA-3045-S
4-Chamber Adjustable Leg Sleeve - Small
GA-3045-M
4-Chamber Adjustable Leg Sleeve - Medium
GA-3045-L
4-Chamber Adjustable Leg Sleeve - Large
GWA-3045-H
4-Chamber Wide Adjustable Leg Sleeve - Half
GWA-3045-S
4-Chamber Wide Adjustable Leg Sleeve - Small
GWA-3045-M
4-Chamber Wide Adjustable Leg Sleeve - Medium
GWA-3045-L
4-Chamber Wide Adjustable Leg Sleeve - Large
GXWA-3045
4-Chamber Extra Wide Adjustable Leg Sleeve

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Accessories (SC-2008-DL)
REF
Description
G8-3035-S
8-Chamber Arm Sleeve - Small
G8-3035-M
8-Chamber Arm Sleeve - Medium
G8-3035-L
8-Chamber Arm Sleeve - Large
G8-3035-SH-S-L
8-Chamber Arm & Shoulder Sleeve - Small, Left
G8-3035-SH-S-R
8-Chamber Arm & Shoulder Sleeve - Small, Right
G8-3035-SH-M-L
8-Chamber Arm & Shoulder Sleeve - Medium, Left
G8-3035-SH-M-R
8-Chamber Arm & Shoulder Sleeve - Medium, Right
G8-3035-SH-L-L
8-Chamber Arm & Shoulder Sleeve - Large, Left
G8-3035-SH-L-R
8-Chamber Arm & Shoulder Sleeve - Large, Right
G8-3045-S
8-Chamber Leg Sleeve - Small
G8-3045-M
8-Chamber Leg Sleeve - Medium
G8-3045-L
8-Chamber Leg Sleeve - Large
GN8-3045-S
8-Chamber Narrow Leg Sleeve - Small
GN8-3045-M
8-Chamber Narrow Leg Sleeve - Medium
GN8-3045-L
8-Chamber Narrow Leg Sleeve - Large
GW8-3045-S
8-Chamber Wide Leg Sleeve - Small
GW8-3045-M
8-Chamber Wide Leg Sleeve - Medium
GW8-3045-L
8-Chamber Wide Leg Sleeve - Large
GXW8-3045
8-Chamber Extra Wide Leg Sleeve
A8-3045-S
8-Chamber Adjustable Leg Sleeve - Small
A8-3045-M
8-Chamber Adjustable Leg Sleeve - Medium
A8-3045-L
8-Chamber Adjustable Leg Sleeve - Large
GWA8-3045-S
8-Chamber Wide Adjustable Leg Sleeve - Small
GWA8-3045-M
8-Chamber Wide Adjustable Leg Sleeve - Medium
GWA8-3045-L
8-Chamber Wide Adjustable Leg Sleeve - Large
GXWA8-3045
8-Chamber Extra Wide Adjustable Leg Sleeve
GBA-3045-S-2
Bio Pants - Small
GBA-3045-M-2
Bio Pants - Medium
GBA-3045-L-2
Bio Pants - Large
GBA-3045-S-L
Bio Abdominal - Small, Left Leg
GBA-3045-S-R
Bio Abdominal - Small, Right Leg
GBA-3045-M-L
Bio Abdominal - Medium, Left Leg
GBA-3045-M-R
Bio Abdominal - Medium, Right Leg
GBA-3045-L-L
Bio Abdominal - Large, Left Leg
GBA-3045-L-R
Bio Abdominal - Large, Right Leg
GV-3010-S-L
Elite 8 Bio Vest - Small, Left
GV-3010-S-R
Elite 8 Bio Vest - Small, Right
GV-3010-M-L
Elite 8 Bio Vest - Medium, Left
GV-3010-M-R
Elite 8 Bio Vest - Medium, Right
GV-3010-L-L
Elite 8 Bio Vest - Large, Left
GV-3010-L-R
Elite 8 Bio Vest - Large, Right
GV-3010-S-2
Elite 8 Vest with Bilateral Arms - Small
GV-3010-M-2
Elite 8 Vest with Bilateral Arms - Medium
GV-3010-L-2
Elite 8 Vest with Bilateral Arms - Large

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Product Specifications
Models: SC-2004-DL, SC-2008-DL
Power Supply Rating: 120-240V, 50/60 Hz
Rated Input: 12VDC, 3A
Electrical Classification: Class II
Applied Part: Type BF
Ingress Protection: IP21
Mains Isolation: Unplug
Mode of Operation: Continuous
Essential Performance: The pump’s cyclical inflation and deflation of the
garment(s)
Cycle Time: 60-120 seconds in 15 second increments
Treatment Time: Continuous or 10-120 minutes in 5 minute increments
Pressure Range: 10-120 mmHg
Precision: 1 mmHg
Accuracy: ± 20%
Features: Adjustable Cycle Time, Compliance/Usage Meter, Focus
Therapy, Play/Pause, Timed Treatment
Warranty: Pump 3 years, garment 1 year
Expected Service Life: 5 years
Software Safety Class: A
Regulatory Classification: AU IIa, CA 2, BR II, EU IIa, US 2
Weight (SC-2004-DL) 3.3 lbs. (1.5 kg)
Weight (SC-2008-DL): 3.65 lbs. (1.66 kg)
Dimensions: 4.5” x 12” x 7.34” (114 mm x 304 mm x 186 mm)

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Environmental Specifications
Consumables and Natural Resources Used During Care and Use
Electrical energy for operation
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
Unplug the pump after charging - unplugging electronic devices when
they are not being used saves electricity
Unplug the pump when not in use - unplugging electronic devices
when they are not being used saves electricity
Do not clean garment soiled - this minimizes the consumables use
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
There are no components which contain stored electrical energy after
the device has been shut off

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Does not contain hazardous substances requiring special handling and
treatment
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
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
IEC 61000-4-2 Electrostatic Discharge Immunity
±8kV contact, ±2, 4, 8, 16kV air discharge
IEC 61000-4-3 Radiated RF Field Immunity
80MHz –2.7GHz, 10V/m, AM 80% at 1kHz
IEC 61000-4-3 Proximity Fields from RF Wireless
Communications Equipment
IEC 60601-1-2, Section 8.10, Table 9
IEC 61000-4-4 Electrical Fast Transients
±2kV/100kHz power, ±1kV/100kHz signal
IEC 61000-4-5 Surge Immunity
±0.5, 1kV line to line, ±0.5, 1, 2kV line to ground
IEC 61000-4-6 Conducted RF Immunity
150kHz - 80MHz, 3VRMS in whole range, 6VRMS in amateur radio and
ISM, AM 80% at 1kHz
IEC 61000-4-8 Magnetic Field Immunity
30A/m, 50 or 60Hz
IEC 61000-4-11 Voltage Dips
0% UTper 0.5 cycles, 0% UTper 1.0 cycle, 70% UTper 25/30
cycles
IEC 61000-4-11 Voltage Interruptions
0% UTper 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
IP21
Ingress protection (against
solids up to 12.5 mm and
dripping water)
Warning: Electricity

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Information for Distributors and Healthcare Providers
Compliance Meter
To see hours of use since last reset, refer to “To See Treatment
Compliance Meter (Hours of Use)” in the Operating Instructions section.
To see pump total hours of use, press “Play/Pause” for 10 seconds while
viewing hours since last reset - “t” will appear followed by the total hours of use.
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 treatment compliance meter and return the pump to factory
settings:
Begin with the device turned off and plugged in
Press and hold the UP, DOWN, and SET buttons simultaneously for 5
seconds
LED display will light up and the buttons can be released
Press “SET” button – LED display will turn off and pump has been reset
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: [e-mail]
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-284 C EN 2021-09