Bio Compression Systems SC-2004-C 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...............................................................3
Warnings and Precautions...........................................................................................5
Operating Instructions..................................................................................................6
Accessories...................................................................................................................9
Product Specifications .................................................................................................9
Environmental Specifications.................................................................................... 11
Symbol Glossary......................................................................................................... 13
Contact Information.................................................................................................... 14

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Introduction
Congratulations on the purchase of your BioCryo Cold Compression System model SC-
2004-C.
Package Contents
• Sequential Circulator pump
• Instructions for use
• Blocker bar
• Garment(s) possibly - packed separately
Intended Use
The BioCryo Cold Compression System model SC-2004-C is a gradient, sequential,
pneumatic compression device, intended for the primary treatment of tendinitis,
hamstring pulls, joint inflammation edema, post-op injuries, soft tissue injuries, acute
sprains, bruises and other musculoskeletal injuries. This device is intended for both
home and hospital use.
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)
• Cryo Therapy is not recommended for patients with lymphedema
• Active cancer except for palliative care
• Other indications as identified by the treating physician
Device Description and Operating Principle
The BioCryo Cold Compression System model SC-2004-OC Sequential Circulator
provides gradient pneumatic compression and cold therapy at the same time.
Sequential gradient compression helps to increase blood flow to the affected area.
Pneumatic compression devices are proven to reduce limb swelling. Garments come
with a water-based gel insert that maintain a constant temperature of 40° F (4° C).

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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.
• 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.

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Front Panel and Key Features
Key Functions
1. Power On/Off Button
2. Pressure Knob
3. Pressure Gauge
4. Garment Connector Bar Ports
5. Auxiliary Air Supply Port (shown with Blocker Bar)
6. Garment Connector Bar
7. Blocker Bar (uninstalled)
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
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• 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
• Cold therapy products for more than 20 minutes every two hours
• 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
• Peripheral arterial occlusive disease
• Circulatory problems or problems in sensing heat or cold
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

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• 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.
Preparing the Device for Use
• Remove garment(s) and cardboard underneath from box
• 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
• Plug power cord into outlet
• Remove garment(s) from plastic bag, unroll, and spread flat
• Place gel insert flat in freezer for 4 hours - do not place directly on metal rack as this
could damage inset
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
• 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

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• Sit in a comfortable reclined position with legs elevated within reach of controls
• Set pressure by turning knob
• Press “Power On/Off” button to turn on
• Run for treatment time determined by physician
• Upon the completion of treatment or to stop treatment, press “Power On/Off” button to
turn off
• Wait until light goes out
• 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 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
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
• Do not store cold therapy garments on metal freezer racks
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

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• 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
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
REF
Description
CI-3035-B
Cryo Insert - Back
CI-3035-E
Cryo Insert - Elbow
CI-3035-H-W
Cryo Insert - Hand/Wrist
CI-3035-SH
Cryo Insert - Shoulder
CI-3045-A
Cryo Insert - Ankle
CI-3045-K
Cryo Insert - Knee
CP-L
BioCryo Gel Insert - Large
CP-M
BioCryo Gel Insert - Medium
CP-S
BioCryo Gel Insert - Small
GC-3035-B
BioCryo Back
GC-3035-EC
BioCryo Elbow
GC-3035-H-W
BioCryo Hand/Wrist
GC-3035-SH-C
BioCryo Isolated Shoulder
GC-3045-A
BioCryo Ankle
GC-3045-KC
BioCryo Knee

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Product Specifications
Models: SC-2004-C, SC-2004-C-230
Electrical Rating: 120 VAC, 60 Hz, 0.5 A or 230 VAC, 50 Hz, 0.5 A
Electrical Classification: Class II
Type Applied Part: Type BF
Ingress Protection: IP20
Mains Isolation: Unplug
Mode of Operation: Continuous
Essential Performance: The pump’s cyclical inflation and deflation of the garment(s)
Cycle Time: 90 ± 10 seconds (inflation 72 seconds - 18 seconds/garment chamber,
deflation 18 seconds)
Pressure Range: 0-120 mmHg
Precision: 2 mmHg
Accuracy: ± 20%
Warranty: Pump 3 years, garment 1 year
Expected Service Life: 5 years
Regulatory Classification: AU IIa, CA 2, BR II, EU IIa, US 2
Weight: 8 lbs. (3.62 kg)
Dimensions: 5.5” x 12” x 8” (140 mm x 305 mm x 203 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 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
• 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

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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
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, 8kV 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
IP20
Ingress protection (against
solids up to 12.5 mm; no
protection from water)
Warning: Electricity

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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-095 G EN 2020-04