The device is a sequential circulator, a pneumatic compression device designed for the treatment of primary or secondary lymphedema, venous insufficiency, chronic venous stasis ulcers, and general swelling of the extremities. It operates by providing gradient pneumatic compression, which helps to increase blood flow and move excess lymph away from affected areas for clearance from the body. The device delivers sequential (distal to proximal) inflation/deflation cycles of compressed air at prescribed pressures. It is suitable for both home and hospital use.
Technical Specifications
The device comes in several models: SC-2004-OC, SC-2004-OC-230, SC-2004FC-OC, SC-2008-OC, and SC-2008-OC-230.
Electrical Rating:
- 120 VAC, 60 Hz, 0.5 A (for 120V models)
- 230 VAC, 50 Hz, 0.5 A (for 230V models)
Electrical Classification: Class II
Type Applied Part: Type BF
Ingress Protection: IP20 (protection against solids up to 12.5 mm; no protection from water)
Mains Isolation: Unplug
Mode of Operation: Continuous
Essential Performance: The pump's cyclical inflation and deflation of the garment(s).
Cycle Times:
- SC-2004-OC: 90 ± 10 seconds (inflation 72 seconds - 18 seconds/garment chamber, deflation 18 seconds)
- SC-2004FC-OC: 60 ± 10 seconds (inflation 50 seconds - 12.5 seconds/garment chamber, deflation 10 seconds)
- SC-2008-OC: 60 ± 10 seconds (inflation 54 seconds - 6.5 seconds/garment chamber, deflation 6 seconds)
Pressure Range: 20-80 mmHg
Precision: 1 mmHg
Accuracy: ± 20%
Dimensions: 4.5" x 11.75” x 7.38” (114 mm x 298 mm x 187 mm)
Weight:
- SC-2004-OC, SC-2004FC-OC: 4.65 lbs. (2.1 kg)
- SC-2008-OC: 5.25 lbs. (2.38 kg)
Warranty: Pump 3 years, garment 1 year
Expected Service Life: 5 years
Regulatory Classification: AU IIa, CA 2, BR II, EU IIa, US 2
Environmental Specifications
Operation Environment:
- Intended for use in a healthcare or home environment.
- NOT intended for 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
Usage Features
Front Panel and Key Functions:
- Power On/Off Button: Controls the device's power.
- Pressure Knob: Adjusts the treatment pressure.
- Garment Connector Bar Ports: Where the garment connector bars are inserted.
- Auxiliary Air Supply Ports: Used with blocker bars.
- Blocker Bars (uninstalled): Used to block unused ports when only one garment is connected to a multi-port pump (e.g., SC-2008-OC).
- Garment Connector Bar: Connects the garment tubing to the pump.
Preparing the Device for Use:
- Remove the pump and garments from packaging, saving packaging for transport and storage.
- Place the pump on a flat, sturdy surface within reach of controls.
- Attach the power cord and plug into an outlet.
- Unroll garments from their plastic bag and spread flat.
Connecting the Garment(s):
- Align the numbers on the garment connector bar with the numbers on the pump.
- Squeeze the sides of the connector bar and insert it into the pump until a "click" is heard.
- For multi-garment pumps (e.g., SC-2008-OC), repeat for additional garments. If using only one garment with a multi-port pump, install blocker bar(s) into unused ports.
Putting the Garment(s) On:
- Leg sleeve: Unzip, place foot in, use straps to guide the garment on, and pull up the zipper to secure.
- Arm sleeve: Slide the arm through the larger opening.
Operating the Device:
- Sit in a comfortable, reclined position with legs elevated.
- Set the desired pressure using the pressure knob.
- Press the "Power On/Off" button to start treatment.
- Run for the physician-determined treatment time.
- To stop treatment, press the "Power On/Off" button again and wait for the light to go out.
- Squeeze the sides of the connector bar and pull to disconnect the garment.
- Press the garment to remove remaining air until it is loose enough to remove.
- Unzip (if applicable) and remove the garment.
Guidelines for Treatment:
- A physician must prescribe settings.
- 50 mmHg is common, but pressure may be adjusted for individual needs and tolerance.
- Fibrotic tissue may require up to 80 mmHg initially, then readjusted to 50 mmHg once softened.
- Patients with a history of Congestive Heart Failure (CHF) should remain in a reclined position with elevated legs during treatment, possibly with divided treatment durations (e.g., twice a day for 30 minutes).
- Patients with a history of Deep Vein Thrombosis (DVT) may require less compression (e.g., 40 mmHg) and possibly divided treatment durations. A negative Doppler study from the physician is suggested.
Warnings and Precautions:
- US federal law restricts this device to sale by or on the order of a physician.
- Read the entire instruction manual before operating.
- Use only accessories and power cords specified or provided by Bio Compression Systems to avoid increased electromagnetic emissions, decreased immunity, or improper operation.
- Portable RF communications equipment (e.g., cell phones) should be kept at least 12" (30 cm) away from the device and power cord to prevent performance degradation.
- Avoid using the device adjacent to or stacked with other equipment.
- Do not use if the pump, accessories, or power cord are damaged or immersed in water.
- Do not use in the presence of flammable anesthetics, an oxygen-rich environment, or an MRI environment.
- Do not use near water, in a wet environment, or where aerosols are being sprayed.
- Do not use while sleeping.
- Do not operate on a soft surface, under a blanket, 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.
- Do not submerge the device or allow liquids to enter.
- Never attempt to open, repair, or modify the device.
- Consult a doctor before use if you have insensitive, irritated, injured skin, or skin conditions in/around treatment sites.
- Examine the device, accessories, and power cord for damage before each use.
- Handle garments with care: do not fold, crease, use near heat, use with sharp objects, clean with abrasive materials, or place in a washing machine or dryer.
- Do not stand or walk while wearing garments.
- Always wear clothing, bandages, or stockings underneath garments for hygiene and to avoid irritation.
- Garments are for single-patient use only; do not share.
- Avoid folding, pinching, or kinking tubing to prevent air flow obstruction.
- Do not wrap tubing around the limb as this can restrict blood flow.
- Keep out of reach of children and pets.
Stop Use and Ask a Doctor If:
- Changes in skin appearance (color changes, blisters, welts, increased swelling) occur.
- You feel burning, itching, increased pain, numbness, or tingling.
- In case of power failure or pump stoppage, release pressure by disconnecting the garment.
Serious Incident Reporting:
- Any serious incident related to the device must be reported to Bio Compression Systems.
- In the EU, incidents should also be reported to the competent authority of the Member State where the user/patient is established.
Maintenance Features
Cleaning:
- The pump, garment, and tubing can be wiped down with a damp (not wet) soft cloth while unplugged.
- For more thorough cleaning or disinfection:
- Pump and tubing: Unplug and wipe down with a damp (not wet) soft cloth with mild antibacterial soap. Do not use bleach.
- Garment Disinfection:
- Disconnect from the pump and open to expose all sides.
- Prepare a solution of 1/3 cup laundry detergent per 1 gallon of warm water (20 mL detergent per 1 L water) in a sink or container large enough for the garment.
- Place the garment in the solution, but do not submerge connectors.
- Soak for 30 minutes with mild agitation every 5-10 minutes. Hand wash with a soft clean cloth for hard-to-remove soil.
- Rinse with warm water and allow to air dry.
- Repeat the process using a solution of 1 cup 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 heat sources and pests.
Servicing and Repairs:
- Contact Bio Compression Systems for servicing. There are no user-serviceable parts.
- Tampering, modifying, or dismantling the device voids the warranty.
- Have your model number and serial number ready when contacting customer service.
Troubleshooting:
- Pump does not turn on:
- Check if the pump is plugged in.
- Examine the power cord for damage; contact Bio Compression Systems if damaged.
- Check the circuit breaker to ensure the outlet has power.
- Contact Bio Compression Systems.
- Garment does not deflate:
- Check the garment connection to the pump.
- Check the garment hose for damage, kinks, or twists.
- Check the garment for damage.
- Contact Bio Compression Systems.
- Pressure seems low:
- Check the garment connection to the pump.
- Check the garment hose for damage, kinks, or twists.
- Check the garment for damage.
- Contact Bio Compression Systems.
- Device is loud or making strange noises:
- Ensure the pump is on a stable surface.
- Assure the stable surface is free and clear of any loose objects.
- Contact Bio Compression Systems.
End of Life Management:
- No components contain stored electrical energy after shut-off.
- Does not contain hazardous substances requiring special handling and treatment.
- Dispose of in an environmentally responsible manner according to regional requirements.
- Contact Bio Compression Systems for disassembly and disposal questions.
General
To Next Page
